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OECD Guideline 413 Subchronic Inhalation Toxicity: 90-Day Study

OECD (2009), Test No. 413: Subchronic Inhalation Toxicity: 90-day Study (OECD
Guidelines for the Testing of Chemicals, Section 4, OECD Publishing) addresses at
point 6 the selection of animal species and provides:
‘Healthy young adult rodents of commonly used laboratory strains should be
employed. The preferred species is the rat. Justification should be provided if
other species are used’.

Directive 2010/63/EU of the European Parliament and of the Council

Article 13(1) and (2) of Directive 2010/63/EU of the European Parliament and of
the Council of 22 September 2010 on the protection of animals used for scientific
purposes (OJ L 276, 20.10.2010, p. 33) provides:
‘Choice of methods
1. Without prejudice to national legislation prohibiting certain types of methods,
Member States shall ensure that a procedure is not carried out if another method
or testing strategy for obtaining the result sought, not entailing the use of a live
animal, is recognised under the legislation of the Union.
2. In choosing between procedures, those which to the greatest extent meet the
following requirements shall be selected:
(a) use the minimum number of animals;
(b) involve animals with the lowest capacity to experience pain, suffering, distress
or lasting harm;
(c) cause the least pain, suffering, distress or lasting harm;
and are most likely to provide satisfactory results’.


On 11 December 2009, the Appellant submitted a registration for the substance
2,3,3,3-tetrafluoropropene (hereinafter ‘the Substance’) at the tonnage level of
1,000 tonnes or more per year.


In the registration dossier submitted the Appellant provided three repeated dose
toxicity studies in the rat (2, 4 and 13 weeks’ exposure) pursuant to Sections
8.6.1 and 8.6.2 of Annexes VIII and IX to the REACH Regulation, a pre-natal
developmental toxicity study and a two-generation reproductive study in the rat
pursuant to Section 8.7.2 of Annex IX and Section 8.7.3 of Annex X respectively,
as well as a pre-natal developmental toxicity study in the rabbit pursuant to
Section 8.7.2 of Annex X.


The toxicological hazard assessment, prepared by the Appellant on the basis of
the variety of rat studies present in the dossier (ranging from acute toxicity,
through sub-chronic toxicity to pre-natal and multi-generation toxicity assays),
showed that the Substance has fairly low potency in the rat. However, the results
in the robust study summary of the pre-natal developmental toxicity study in the
rabbit via inhalation showed a potent toxicity, with lethality at doses much lower
as compared with rats.


On 26 April 2010, the Agency initiated a dossier compliance check of the
Appellant’s registration dossier for the Substance. Further to this, the Agency
prepared a draft decision pursuant to Article 41(3) of the REACH Regulation by
which its intention was to require the Appellant to submit, pursuant to Articles
10(a)(vi) and (vii), 12(1)(e), 13(3), 41(1)(a) and 41(3), as well as Section 8.6.4