Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The study was read across from DTPMP-H (CAS 15827-60-8), which is structurally analogous to the registered substance BHMT-H (CAS 34690 -00 -1) and in the equivalent pH range (pH <2). It was therefore deemed suitable for read across. The Unilever study was selected as the key study and for read across because it was the most recent available study, it also had the most 'critical' details regarding the methodology, such as route of induction and challenge. Unfortunately the number of animals used would not be sufficient to meet current guidelines. A supporting Buehler test (P&G, 1977; reliability score 2) also gave negative results for DTPMP. In this study an adequate number of animals was used, but other details regarding the methodology were missing from the report. Together these studies are supportive of a negative result.

Migrated from Short description of key information:
The available skin sensitisation study was read across from DTPMP-H (CAS 15827-60-8). A guinea pig maximisation study was conducted before OECD TG 406 and GLP (reliability score 2), in which DTPMP was found not sensitising to the skin of guinea-pigs (Unilever 1979).

Justification for selection of skin sensitisation endpoint:
Study conducted in accordance with appropriate OECD guideline and in compliance with GLP.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The classification decision is based on read across from DTPMP-H (CAS 15827-60-8) which is a structurally analogous substance to the registered substance BHMT-H (CAS 34690-00-1) with similar pH. The available data suggest that DTPMP is not a skin sensitiser and therefore no classification is proposed for the registered substance in accordance with current regulation (EC 1272/2008)