#2340851
Staidéar saofa crómasóim mamaigh in vitro nó staidéar micreanúicléis mamaigh in vitro”;
In vitro mammalian chromosomal aberration study or in vitro mammalian micronucleus study’;
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#2340846
Sa staidéar in vivo tabharfar aghaidh ar an imní maidir le saobhadh crómasóim nó maidir le sóchán géine, nó ar an dá ábhar imní, de réir mar is iomchuí.
The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate.
#2340848
Sa staidéar in vivo tabharfar aghaidh ar an imní maidir le saobhadh crómasóim nó maidir le sóchán géine, nó ar an dá ábhar imní, de réir mar is iomchuí.”;
The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both as appropriate.’;
#2340904
Sa staidéar géineatocsaineachta cille sómaí mamaigh in vivo tabharfar aghaidh ar an imní maidir le saobhadh crómasóim nó maidir le sóchán géine, nó ar an dá ábhar imní, de réir mar is iomchuí.
The in vivo mammalian somatic cell genotoxicity study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.
#2340907
Sa staidéar géineatocsaineachta gaiméite mamaigh in vivo tabharfar aghaidh ar an imní maidir le saobhadh crómasóim nó maidir le sóchán géine, nó ar an dá ábhar imní, de réir mar is iomchuí.
The in vivo mammalian germ cell genotoxicity study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.
#2340954
Sa staidéar tabharfar aghaidh ar shaobhadh crómasóim nó ar shóchán géine, de réir mar is iomchuí, ábhair nár tugadh aghaidh orthu sa chéad staidéar géineatocsaineachta cille sómaí mamaigh in vivo.
The second study shall address chromosomal aberration or gene mutation, as appropriate, which has not been addressed by the first in vivo mammalian somatic cell genotoxicity study.
#2340956
Sa staidéar tabharfar aghaidh ar shaobhadh crómasóim nó ar shóchán géine, de réir mar is iomchuí, ábhair nár tugadh aghaidh orthu sa chéad staidéar géineatocsaineachta gaiméite mamaigh in vivo.
The second study shall address the chromosomal aberration or gene mutation, as appropriate, which has not been addressed by the first in vivo mammalian germ cell genotoxicity study.
#2340969
Sa staidéar in vivo tabharfar aghaidh ar an imní maidir le saobhadh crómasóim nó maidir le sóchán géine, nó ar an dá ábhar imní, de réir mar is iomchuí.
The in vivo study shall address the chromosomal aberration concern or the gene mutation concern or both, as appropriate.
#2340842
tá sonraí leordhóthanacha ar fáil ón staidéar in vivo comhfhreagrach, (is é sin an staidéar saofa crómasóim in vivo (nó maidir le micreanúicléas) i dtaca le pointe 8.4.2 nó an staidéar sócháin géine mamaigh in vivo i dtaca le pointe 8.4.3),
adequate data from the corresponding in vivo study, (namely in vivo chromosomal aberration (or micronucleus) study regarding point 8.4.2 or in vivo mammalian gene mutation study regarding point 8.4.3), are available,
#2340953
An dara staidéar géineatocsaineachta cille sómaí mamaigh in vivo, má bhíonn toradh deimhneach in aon cheann de na staidéir géineatocsaineachta in vitro dá dtagraítear in Iarscríbhinn VII nó in Iarscríbhinn VIII, toradh deimhneach ar ábhar imní é maidir le saobhadh crómasóim mar aon le sóchán géine.
A second in vivo mammalian somatic cell genotoxicity study, if there is a positive result in any of the in vitro genotoxicity studies referred to in Annex VII or Annex VIII, which gives rise to both chromosomal aberration concern and gene mutation concern.
#2340955
An dara staidéar géineatocsaineachta gaiméite mamaigh in vivo, má tá toradh deimhneach i staidéir géineatocsaineachta cille sómaí mamaigh in vivo, toradh deimhneach ar ábhar imní é maidir le saobhadh crómasóim mar aon le sóchán géine.
A second in vivo mammalian germ cell genotoxicity study, if there is a positive result in in vivo mammalian somatic cell genotoxicity studies, which gives rise to both chromosomal aberration concern and gene mutation concern.
#3037611
Chuir an tÚdarás in iúl sa tuairim uaidh an 31 Eanáir 2023, bunaithe ar thástáil shaobhadh crómasóim in vitro agus ar thástáil micreanúicléas in vivo, nárbh fhéidir gníomhaíocht aineoigineach a d’fhéadfadh a bheith ag hidreaclóiríd róibeinidín a chur as an áireamh, agus nár cuireadh aon fhaisnéis ar fáil san iarratas maidir le haineoigineacht fhéideartha hidreaclóiríde róibeinidín.
The Authority stated in its opinion of 31 January 2023 that, based on the available in vitro chromosomal aberration test and the results of the in vivo micronucleus test, the potential aneugenic activity of robenidine hydrochloride could not be excluded, and that no information on the potential aneugenicity of robenidine hydrochloride was made available in the application.
#2157834
Ina theannta sin, an 1 Deireadh Fómhair 2019, d’iarr an t-iarratasóir ar an gCoimisiún go gcosnófaí sonraí dílseánaigh i gcás roinnt staidéar a cuireadh isteach mar thaca leis an iarratas, eadhon na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.
On 1 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via nuclear magnetic resonance (‘NMR’) of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.
#2157839
Sa tuairim eolaíoch ón Údarás, mheas sé nach bhféadfadh sé teacht ar a chuid conclúidí maidir le sábháilteacht 3-FL gan na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil micreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.
In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.
#2157840
Tar éis dó tuairim eolaíoch an Údaráis a fháil, d’iarr an Coimisiún ar an iarratasóir soiléiriú breise a thabhairt maidir leis an réasúnú a cuireadh ar fáil i dtaca lena éileamh dílseánaigh ar na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (‘NMR’) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro i lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar tocsaineachta béil 3 seachtaine ar bhainbh nuabheirthe.
Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.