of Annex X to the REACH Regulation, inter alia a 90-day repeated dose toxicity
study in the rabbit by inhalation (Test Method (‘TM’) B.29 of Regulation (EC) No
440/2008 or OECD Test Guideline (‘TG’) 413). The Agency draft decision further
requested that the study protocol should be modified with additional clinical
pathology and histopathological evaluations to examine effects on reproductive
organs, specifically as described in OECD TG 416 and in particular paragraphs 29
to 32, 39 and 41 to 45 thereof. The modified repeated dose toxicity study in the
rabbit by inhalation as described in this paragraph is hereinafter referred to as
The draft decision gave the following reasons for requiring the Study:
The death of pregnant rabbits in the Appellant’s prenatal developmental
toxicity testing on rabbits satisfies the criterion ’toxicity of particular
concern’ as set out in Section 8.6.4 of Annex X;
The available evidence is inadequate for toxicological evaluation and/or risk
characterisation because the data submitted shows that the rabbit is more
sensitive to toxicity from the Substance as compared with the rat; and
The available information on the toxicity of the Substance on the rabbit is
inadequate for toxicological evaluation and/or risk characterisation.
On 19 August 2010, the Agency notified the draft decision to the Appellant and
invited it, pursuant to Article 50(1) of the REACH Regulation, to submit comments
on the draft decision by 20 September 2010. At the same time, the Agency
offered the Appellant an opportunity to discuss the scientific background to the
draft decision with the Agency.
On 2 September 2010, the Agency and the Appellant held a teleconference to
discuss the draft decision.
On 17 September 2010, the Appellant submitted comments on the draft decision,
and subsequently on 30 September 2010, submitted a revised IUCLID file to the
Agency with certain additional information.
On 29 October 2010, the Agency, pursuant to Article 51(1) of the REACH
Regulation, notified the draft decision to the Member States Competent
Authorities (hereinafter the ‘MSCAs’ or ‘MSCA’ if singular) and invited them to
By 28 November 2010, the Agency received comments and proposals for
amendments from five MSCAs.
On 1 December 2010, the Agency notified the MSCAs’ comments to the Appellant
in accordance with Article 51(5) of the REACH Regulation, and invited the
Appellant to comment on the proposed amendments. On 21 December 2010, the
Appellant submitted further comments to the Agency.
The Agency considered the MSCAs’ proposals for amendments, and amended the
draft decision. These amendments did not however relate to the Study.
On 13 December 2010, the Agency referred the draft decision (as amended) to
the Member State Committee (hereinafter ‘MSC’), in accordance with Article 51(4)
of the REACH Regulation.
On 1, 2 and 3 February 2011, a meeting of the MSC (MSC-16) took place at which
the Agency’s draft decision was discussed. The Appellant participated at the
meeting as the case owner and was present at the initial discussions of the MSC
on the Agency’s draft decision. Following certain amendments to the draft
decision, which pertained only to the time limit accorded to the Appellant to
submit the results of the Study, the MSC reached a unanimous agreement on the
Agency’s draft decision.