Léireofar go soiléir leis na treoracha úsáide nár cheart an fheiste a úsáid ar chodanna den chraiceann lena mbaineann dóchúlacht mhéadaithe d’ailse chraicinn, créachtaí oscailte nó gríos, nó réigiúin ata, dhearga, ghreannaithe, ionfhabhtaithe nó athlasta nó grís craicinn.
The instructions for use shall clearly indicate that the device is not to be used on skin parts which have an increased likelihood of skin cancer, open wounds or rashes, or swollen, red, irritated, infected, or inflamed areas or skin eruptions.
#2846430
Tháinig an tÚdarás ar an gconclúid freisin gur cheart an ullmhóid a mheas mar íogróir riospráide ach, in éagmais sonraí, nach raibh sé in ann teacht ar chonclúid maidir le greannúcraicinn na hullmhóide don chraiceann.
The Authority also concluded that the preparation should be considered a respiratory sensitiser but, in the absence of data, could not conclude on the irritancy potential of the preparation to skin.
#293554
3.2.2.3. Má bhíonn substaint ard-tocsaineach go deirmeach, ní bhíonn staidéar maidir le greannú/creimeadh craicinn praiticiúil, toisc gur mó go mór méid na substainte tástála a bheadh le húsáid ná an dáileog thocsaineach, agus dá bhrí sin, gur bás na n-ainmhithe a bheadh mar thoradh air.
3.2.2.3. If a substance is highly toxic by the dermal route, a skin irritation/corrosion study is not practicable since the amount of test substance to be applied considerably exceeds the toxic dose and, consequently, results in the death of the animals.
#293555
Nuair a dhéantar breathnuithe ar ghreannú/creimeadh craicinn i staidéir ghéarthocsaineachta, suas tríd an dáileog theorann, níl tástáil bhreise riachtanach, ar choinníoll go mbíonn na caoluithe a úsáidtear agus na speicis a thástáltar coibhéiseach.
When observations are made of skin irritation/corrosion in acute toxicity studies and are observed up through the limit dose, additional testing is not needed, provided that the dilutions used and species tested are equivalent.
#293556
3.2.2.4. Déanfar an fhaisnéis go léir thuas atá ar fáil maidir le substaint a úsáid chun a dhéanamh amach an bhfuil gá le tástáil in vivo maidir le greannúcraicinn.
3.2.2.4. All the above information that is available on a substance shall be used in determining the need for in vivo skin irritation testing.
#293592
Nuair a bhíonn sé i gceist an meascán a thástáil, moltar do lucht aicmithe úsáid a bhaint as straitéis chisealta a bheidh bunaithe ar thromachar na fianaise mar a áirítear sna critéir chun substaintí a aicmiú maidir le creimeadh agus greannúcraicinn (mír 3.2.2.5), chun cuidiú le haicmiú cruinn a chinntiú chomh maith le tástáil neamhriachtanach ainmhithe a sheachaint.
When considering testing of the mixture, classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and irritation (paragraph 3.2.2.5), to help ensure an accurate classification as well as avoid unnecessary animal testing.
#293597
3.2.3.2.1. I gcás nach mbíonn an meascán féin tástáilte chun a ghuaiseacha maidir le greannú/creimeadh craicinn a dhéanamh amach, ach go mbíonn sonraí leordhóthanacha ar fáil faoi na comhábhair aonair agus faoi mheascáin ghaolmhara a tástáladh chun na hairíonna de ghuaiseacha an mheascáin a shainaithint go sásúil, úsáidfear na sonraí sin de réir na rialacha eachtarshuímh a leagtar amach i roinn 1.1.3.
3.2.3.2.1. Where the mixture itself has not been tested to determine its skin irritation/corrosion hazards, but there are sufficient data on the individual ingredients and similar tested mixtures to adequately characterise the hazards of the mixture, these data shall be used in accordance with the bridging rules set out in section 1.1.3.
#293599
3.2.3.3.1. D'fhonn úsáid a bhaint as na sonraí go léir atá ar fáil chun guaiseacha meascán maidir le greannú/creimeadh craicinn a aicmiú, rinneadh an toimhde seo a leanas agus cuirtear i bhfeidhm í, nuair is cuí, maidir leis an gcur chuige cisealta:
3.2.3.3.1. In order to make use of all available data for purposes of classifying the skin irritation/corrosion hazards of mixtures, the following assumption has been made and is applied where appropriate in the tiered approach:
#293601
is iad na "comhábhair ábhartha" de mheascán ná iadsan atá i láthair i dtiúchan 1 % (w/w maidir le solaid, leachtanna, deannaigh, ceocháin agus gala agus v/v maidir le gáis) nó níos mó, mura bhfuil toimhde ann (e.g., i gcás comhábhar creimneach) go bhfuil comhábhar, atá i láthair i dtiúchan níos lú ná 1 %, fós ábhartha chun an meascán a aicmiú maidir le greannú/creimeadh craicinn.
the "relevant ingredients" of a mixture are those which are present in concentrations of 1 % (w/w for solids, liquids, dusts, mists and vapours and v/v for gases) or greater, unless there is a presumption (e.g., in the case of corrosive ingredients) that an ingredient present at a concentration of less than 1 % can still be relevant for classifying the mixture for skin irritation/corrosion.
#293611
3.2.3.3.5. Uaireanta, d'fhéadfadh sonraí iontaofa a thaispeáint nach bhfuil guais chomhábhair soiléir i meascán maidir le greannú/creimeadh craicinn nuair atá sé i láthair ar leibhéal os cionn na dteorainneacha cineálacha tiúchana atá luaite i dTábla 3.2.3 agus i dTábla 3.2.4.
3.2.3.3.5. On occasion, reliable data may show that the skin corrosion/irritation hazard of an ingredient will not be evident when present at a level above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4.
#293613
Ar ócáidí eile, nuair a mheastar nach mbeidh guais chomhábhair maidir le greannú/creimeadh craicinn follasach nuair a bhíonn sé i láthair ar leibhéal os cionn na dteorainneacha cineálacha tiúchana atá luaite i dTábla 3.2.3 agus i dTábla 3.2.4, cuirfear tástáil an mheascáin san áireamh.
On other occasions, when it is expected that the skin corrosion/irritation hazard of an ingredient is not evident when present at a level above the generic concentration limits mentioned in Tables 3.2.3 and 3.2.4, testing of the mixture shall be considered.
#293647
Tríd is tríd, leagfar béim go príomha ar bhreithiúnas saineolaithe, agus taithí an duine ar an tsubstaint á chur san áireamh, agus ina dhiaidh sin ar thoradh tástála maidir le greannúcraicinn agus ar thorthaí ó mhodhanna malartacha dea-bhailíochtaithe.
Generally, primary emphasis shall be placed upon expert judgement, considering human experience with the substance, followed by the outcome of skin irritation testing and of well-validated alternative methods.
#293668
Nuair a bheidh tástáil ar an meascán á breithniú, moltar do lucht aicmithe úsáid a bhaint as straitéis chisealta bunaithe ar thromachar na fianaise mar a áirítear sna critéir le haghaidh substaintí a aicmiú maidir le creimeadh craicinn agus damáiste tromchúiseach súile agus greannú súile, chun cuidiú le haicmiú cruinn a chinntiú chomh maith le tástáil neamhriachtanach ainmhithe a sheachaint.
When considering testing of the mixture classifiers are encouraged to use a tiered weight of evidence strategy as included in the criteria for classification of substances for skin corrosion and serious eye damage and eye irritation to help ensure an accurate classification, as well as avoid unnecessary animal testing.
#293687
Uaireanta eile, nuair a mheastar nach mbeidh guaiseacha comhábhair maidir le greannú/creimeadh craicinn nó na héifeachtaí inchúlaithe/dochúlaithe súile a bhíonn ag comhábhar follasach ar an gcomhábhar sin a bheith i láthair ar leibhéal os cionn na dteorainneacha cineálacha tiúchana a luaitear i dTábla 3.3.3 agus i dTábla 3.3.4, breithneofar tástáil a dhéanamh ar an meascán.
On other occasions, when it is expected that the skin corrosion/irritation hazards or the reversible/irreversible eye effects of an ingredient will not be evident when present at a level above the generic concentration limits mentioned in Tables 3.3.3 and 3.3.4, testing of the mixture shall be considered.
#1945121
Má d’eascair cinneadh cinntitheach cheana féin, maidir le haicmiú substainte nó maidir le heaspa riosca an ghreannaithecraicinn, as na torthaí ó cheann amháin den dá staidéar atá liostaithe i bpointe (b) agus i bpointe (c) i gcolún 1 den ró seo, ní gá an dara staidéar a dhéanamh
If results from one of the two studies listed in point (b) or point (c) in column 1 of this row already allow conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study does not need to be conducted
#1945122
Ní chuirfear staidéar in vivo maidir le creimeadh ná greannúcraicinn san áireamh ach amháin mura bhfuil na staidéir in vitro atá liostaithe i bpointe (b) agus i bpointe (c) i gcolún 1 den ró seo infheidhme, nó mura bhfuil torthaí na staidéar sin leordhóthanach maidir le haicmiú agus maidir le measúnú riosca
An in vivo study for skin corrosion or irritation shall be considered only if the in vitro studies listed in points (b) and (c) in column 1 of this row are not applicable, or the results of these studies are not adequate for classification and risk assessment
#1945123
Measfar staidéir in vivo ar chreimeadh nó ar ghreannúcraicinn a rinneadh nó a tionscnaíodh roimh an 15 Aibrean 2022 a bheith iomchuí chun aghaidh a thabhairt ar an gceanglas seo maidir le faisnéis
In vivo studies for skin corrosion or irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement
#1945307
I dtaca leis an dá staidéar atá liostaithe i bpointí (b) agus (c) i gcolún 1 den ró seo, má thángthas cheana féin leis na torthaí ó cheann amháin den dá staidéar sin ar chinneadh cinntitheach maidir le haicmiú táirge nó meascáin nó maidir le heaspa riosca an ghreannaithecraicinn, ní gá an dara staidéar a dhéanamh
If results from one of the two studies listed in points (b) or (c) in column 1 of this row already allow conclusive decision on the classification of product or mixture or on the absence of skin irritation potential, the second study does not need to be conducted
#1945308
Ní chuirfear staidéar in vivo ar chreimeadh ná greannúcraicinn san áireamh ach amháin mura bhfuil na staidéir in vitro atá liostaithe i bpointí (b) agus (c) i gcolún 1 den ró seo infheidhme, nó mura bhfuil torthaí na staidéar sin leordhóthanach maidir le haicmiú agus maidir le measúnú riosca agus mura bhfuil an modh ríofa nó na prionsabail idirlinne atá leagtha síos i Rialachán (CE) Uimh. 1272/2008 infheidhme
An in vivo study for skin corrosion or irritation shall be considered only if the in vitro studies listed in points (b) and (c) in column 1 of this row are not applicable, or the results of these studies are not adequate for classification and risk assessment and the calculation method or bridging principles laid down in Regulation (EC) No 1272/2008 are not applicable
#1945309
Measfar staidéir in vivo ar chreimeadh nó ar ghreannúcraicinn a rinneadh nó a tionscnaíodh roimh an 15 Aibreán 2022 a bheith iomchuí chun aghaidh a thabhairt ar an gceanglas seo maidir le faisnéis
In vivo studies for skin corrosion or irritation that were carried out or initiated before 15 April 2022 shall be considered appropriate to address this information requirement
#2122983
I gcás úsáideoirí na mbreiseán agus na réamh-mheascán, bunóidh oibreoirí gnólachtaí beathaithe nósanna imeachta oibríochtúla agus bearta eagraíochtúla chun aghaidh a thabhairt ar rioscaí a d’fhéadfadh eascairt as ionanálú, as greannúcraicinn agus as greannú súl agus as íogrú deirmeach.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, skin and eye irritation and dermal sensitization, resulting from its use.
#2125246
Dúirt an tÚdarás go bhfuil mionsonraí maidir le géarthocsaineacht, greannú, íogrú craicinn agus ionálú gearrthéarmach ar fáil go poiblí ar shuíomh gréasáin na Gníomhaireachta Eorpaí Ceimiceán (ECHA) agus gur cheart iad a chomhtháthú san iarratas chun forbhreathnú iomlán a fháil ar an tsubstaint bhunúsach.
The Authority stated that details on acute toxicity, irritation, skin sensitisation and short-term inhalation are publicly available on the European Chemicals Agency (ECHA) website and they should have been integrated in the application to have a complete overview of the basic substance.
#2306263
I gcás úsáideoirí an bhreiseáin agus na réamh-mheascán, bunóidh oibreoirí gnólachtaí beathaithe nósanna imeachta oibríochtúla agus bearta eagraíochtúla chun aghaidh a thabhairt ar na rioscaí a d’fhéadfadh eascairt as a n-úsáid: íogróir riospráide féideartha, greannúcraicinn féideartha agus íogróir súl nó íogróir deirmeach féideartha.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use: a potential respiratory sensitiser, potential skin irritant and potential eyes or dermal sensitiser.
#2480642
Tháinig sé ar an gconclúid freisin go meastar gurb ionann agus riosca do shláinte an úsáideora é vitimín B12 i bhfoirm cianacóbalaimín arna tháirgeadh ag Ensifer adhaerens CNCM I-5541 mar gheall ar a chion ard iontocsaine, an nochtadh ionanálaithe a bhféadfadh a bheith ann nuair a láimhseáiltear na réamh-mheascán agus an greannúcraicinn agus greannú súl a dtuairiscítear ina leith.
It also concluded that due to its high endotoxin content, potential inhalation exposure when handling premixtures and its reported irritancy to skin and eyes, vitamin B12 in the form of cyanocobalamin produced by Ensifer adhaerens CNCM I-5541 is considered to pose a risk to user health.
#2516418
Maidir le sábháilteacht úsáideoir an bhreiseáin sin, ní fhéadfadh an tÚdarás teacht ar chonclúid maidir leis an ngreannúcraicinn nó súl, ná leis an íogrú deirmeach a d’fhéadfadh sulfáit L-lísín a dhéanamh.
With respect to the safety of the user of that additive, the Authority could not conclude on the potential of L-lysine sulphate to be irritant to skin or eyes, or on its potential to be a dermal sensitiser.
#2552639
éifeachtaí áitiúla a bhaineann le creimeadh/greannúcraicinn nó damáiste/greannú súile, i gcomhréir le Rialachán (CE) Uimh. 1272/2008, áiritheoidh sé go n-íoslaghdófar risíocht don phobal i gcoitinne trí bhearta maolaithe riosca iomchuí.
local effects concerning skin corrosion/irritation or eye damage/eye irritation, in accordance with Regulation (EC) No 1272/2008, shall ensure that exposure to the general public is minimised by appropriate risk mitigation measures.
#2569823
Chomh maith leis sin, léireofar go soiléir leis na treoracha úsáide nár cheart an fheiste a úsáid i gcás créachtaí oscailte ná gríos, ná réigiúin ata, dhearga, ghreannaithe, ionfhabhtaithe nó athlasta ná grís craicinn, ina dtiocfaidh comhchodanna den fheiste i dteagmháil leis na réigiúin sin.
The instructions for use shall also clearly indicate that the device is not to be used in case of open wounds or rashes, or swollen, red, irritated, infected, or inflamed areas or skin eruptions, where components of the device will come into contact with these areas.
#2569853
De réir na fianaise eolaíche atá ar fáil maidir le trealamh a beartaíodh le haghaidh spreagadh inchinne lena gcuirtear sruthanna leictreacha nó réimsí maighnéadacha nó leictreamaighnéadacha i bhfeidhm lena dtrasnaítear an cráiniam chun gníomhaíocht néarónach san inchinn a mhodhnú dá dtagraítear i Roinn 6 d’Iarscríbhinn XVI a ghabhann le Rialachán (AE) 2017/745, amhail iad siúd a bhaineann le spreagadh maighnéadach trascráiniach nó spreagadh leictreach trascráiniach, d’fhéadfadh fo-iarsmaí a bheith mar thoradh ar úsáid táirgí den sórt sin, mar shampla, forbairt inchinne neamhghnách, patrúin neamhghnácha ghníomhaíocht na hinchinne, tomhaltas meitibileach a mhéadú, tuirse, imní, greannaitheacht, tinnis chinn, bíogadh na matán, ticeanna, taomanna, veirtige agus greannúcraicinn ag an láthair leictreoidí.
According to available scientific evidence on equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain as referred to in Section 6 of Annex XVI to Regulation (EU) 2017/745, such as those for transcranial magnetic stimulation or transcranial electric stimulation, the use of such products may cause side effects, for example, atypical brain development, abnormal patterns of brain activity, increase metabolic consumption, fatigue, anxiety, irritability, headaches, muscle twitches, tics, seizures, vertigo and skin irritation at the electrode site.
#2714868
Tháinig sé ar an gconclúid freisin gur cheart na hullmhóidí sin a mheas mar íogróir riospráide féideartha, agus in éagmais aon sonraí, níorbh fhéidir leis teacht ar chonclúid maidir leis an ngreannúcraicinn nó súl, ná maidir leis an íogrú deirmeach, a d’fhéadfadh na breiseáin sin a dhéanamh.
It also concluded that those preparations should be considered a potential respiratory sensitiser, and that in the absence of data, it could not conclude on the irritancy potential of the additives to skin and eyes or on its dermal sensitisation potential.
#2734394
Sholáthair an t-iarratasóir an bhileog sonraí sábháilteachta a cheanglaítear i gcomhréir le Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle lena léirítear go bhféadfadh an breiseán a bheith ina chúis le greannú súl agus craicinn.
The applicant provided the safety data sheet required in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council which demonstrates that the additive may cause eyes and skin irritation.
#2959838
Luaigh sé freisin gur cheart an ullmhóid a mheas mar ghreannaitheoir súl féideartha agus mar íogróir riospráide, cé nach bhféadfaí aon chonclúidí a bhaint amach maidir le greannúcraicinn agus poitéinseal íograithe na hullmhóide.
It further stated that the preparation should be considered a potential eye irritant and a respiratory sensitiser, while no conclusions could be drawn on the skin irritancy and sensitisation potential of the preparation.
#3139165
Tháinig sé ar an gconclúid freisin nach greannaitheoir súl é ach in éagmais sonraí, ní féidir teacht ar aon chonclúid maidir leis an ngreannúcraicinn ná súl a d’fhéadfadh sé a dhéanamh ná maidir leis an íogrú deirmeach ná riospráide a d’fhéadfadh sé a dhéanamh.
It also concluded that the extract under assessment is not an eye irritant but that in the absence of data, no conclusion can be drawn on its potential to be a skin irritant and a dermal and respiratory sensitiser.