The European Chemicals Agency (ECHA) Board of Appeal has annulled an ECHA decision requiring additional animal toxicity testing of the low global warming potential refrigerant HF-1234yf (2,3,3,3-tetrafluoropropene) and sent the case to ECHA for re-examination.
The Board of Appeal found that ECHA’s decision breached Article 25(1) of the REACH Regulation requiring testing on vertebrate animals only to be undertaken as a last resort, and the requirement to ensure that the minimum number of animals would be used if testing on vertebrate animals is required.
In addition, the Board of Appeal found that ECHA’s decision was disproportionate as the appropriateness of, and necessity for, the requested study had not been demonstrated nor was the requested study shown to be the least onerous option to achieve the objectives of the contested decision.
Honeywell Belgium had appealed the 2010 ECHA ruling for the extended study based on the following arguments:
Information on the sub-chronic toxicity endpoint in question were satisfied by the inclusion of a 90-day inhalation test in rats in accordance with the REACH Regulation and the corresponding ECHA Guidelines on endpoint specific information requirements;
There is no test method laid down in a European Commission Regulation or in other international test methods as regards a 90-day inhalation study in rabbits;
The requested study in rabbits is almost unprecedented;
The results from a 90-day inhalation test in rabbits are very unlikely to be of any scientific value or to provide additional information on the safety of the substance, in part because of the problems in conducting such a test on rabbits, and therefore will only result in the unnecessary sacrifice of vertebrate animals;
The requirement to conduct a 90-day inhalation study in rabbits is disproportionate as other tests could and should be conducted first;
These other tests may provide sufficient data and therefore further consultations with the Agency are required to decide whether additional testing is necessary; and
The requirement for the appellant to conduct a 90-day inhalation test in rabbits has been adopted without consultation on the development of appropriate test methods.