Registration Dossier

Administrative data

Description of key information

There are no data on the ammonium salt of ATMP. However  read across data from a well conducted chronic toxicity/carcinogenicity study (Biodynamics Inc, 1979c; rel 2), CP42902 (ATMP) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was greater than 500 mg/kg bw/day.

Key value for chemical safety assessment

Mode of Action Analysis / Human Relevance Framework

Additional information

There is no ATMP ammonium salt test data for this particular endpoint. However,the category hypothesis is that all the members are various ionised forms of the acid 6419-19-8. Read across data from a 24 month chronic toxicity/carcinogenicity study with the parent acid (ATMP) in rats reported a NOAEL for carcinogenicity and general toxicity >500 mg/kg bw/day. (Biodynamics Inc, 1979c; rel 2) 

The properties and role of ammonia present in solutions of this salt have been given due consideration. Ammonia has been evaluated in detail at EU level. In the harmonised hazard assessment aqueous ammonia is not classified for repeated dose toxicity. Therefore it is considered that ammonia in the substance contributes no additional hazard in respect of this endpoint.

Justification for classification or non-classification

Based on the read across data from ATMP and the fact that the presence of ammonia does not contribute any additional hazard, it is concluded that there is no requirement for classification.