2024-03-15 10:59:15
Substances resulting from the reaction of diphenylamine with nonene (branched) (BNPA) and from the reaction of N-phenyl-benzenamine with 2,4,4-trimethylpentene are substituted diphenylamines, UVCB type.
Substituted diphenylamines are used in lubricants, greases, cutting fluids, hydraulic fluids and in the manufacture of plastics. They enter into the composition of many products such as washing fluids, car care products, paints, perfumes and deodorants or even lubricants in engine oils and brake fluids.
These substances are currently not subject to harmonized classification at European level within the framework of the CLP regulation (classification, labeling and packaging of products). With a view to proposing a harmonized classification at European level, ANSES assessed their reprotoxic properties for human health and their toxicity for organisms in the aquatic environment.
Proven effects on human fertility and development
Concerning the evaluation of toxic effects for reproduction, the two substances are not the subject of an identical data set. A cross-reading based on structural and toxicological similarities was applied between these two substances in order to compensate for unavailable toxicological information. This approach made it possible to consolidate the analysis and conclude that established effects on fertility and developmentfor both substances.
Effects on female fertility have been demonstrated in several reproduction studies conducted in rats. Additionally, developmental effects have been reported in rodents, characterized primarily by effects on the central nervous system. On this basis, both substances are presumed toxic to human reproduction.
Chronic toxicity to aquatic organisms
Regarding environmental hazards, available studies for BNPA and the reaction products of N-phenyl-benzenamine with 2,4,4-trimethylpentene show chronic toxicity to aquatic organisms and indicate, in both cases, that Daphnia is the most sensitive species. The concentrations inducing harmful effects are, however, specific to each of the two substances. A more severe classification is assigned to BNPA based on available data.
The two classification proposals put out for public consultation
For all these reasons, ANSES proposes that BNPA substances and reaction products of N-phenyl-benzenamine with 2,4,4-trimethylpentene are classified and labeled as follows under the CLP Regulation :
BNPA:
Reproductive toxicity; category 1B (H360FD: May damage fertility. May harm the fetus). Hazardous for the aquatic environment, category 1 (H410, Very toxic to aquatic organisms, causes long-term adverse effects).
Reaction products of N-phenyl-benzenamine with 2,4,4-trimethylpentene:
Reproductive toxicity; category 1B (H360FD: May damage fertility. May harm the fetus). Hazardous for the aquatic environment, category 2 (H411, toxic to aquatic organisms, causes long-term adverse effects).
The harmonized classification proposals for BNPA substances and reaction products of N-phenyl-benzenamine with 2,4,4-trimethylpentene were made available for public consultation on the ECHA website on March 4, 2024, for a period of two months, in order to allow all stakeholders to comment on these proposals, providing, where appropriate, additional scientific arguments and information available to them. Comments can be submitted via a dedicated form on the ECHA website.
Following this consultation stage, ANSES will be responsible for responding to the comments received. The initial proposal, the comments and the responses provided by ANSES will be transmitted to the ECHA Risk Assessment Committee, which will then issue its opinion concerning the classification of BNPA substances and reaction products of N-phenyl-benzenamine with 2,4,4-trimethylpentene.
On the basis of this opinion, the European Commission will then develop the regulatory texts to include the classifications retained in the CLP regulation.
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