Registration Dossier

Administrative data

Description of key information

In the key skin sensitisation study, conducted according to OECD 406 TG and in compliance with GLP, the test substance Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate was reported to be not sensitising to skin (Charles River, 2018).

Key value for chemical safety assessment

Skin sensitisation

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

In the key skin sensitisation study, conducted according to OECD 406 TG and in compliance with GLP, the test substance Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate was reported to be not sensitising to skin (Charles River, 2018).

At induction phase, 100% of test material was topically applied to the left flank of 10 male and 10 female guinea pigs for 6 hours under occlusive dressing once a week for three consecutive weeks. Approximately 2 weeks after the last induction exposure the animals were challenge-dosed for detection of sensitisation by topical application of 100% test substance to the right flank of their backs. Reactions to challenge dosing were evaluated at 24 and 48 hours post-exposure. Body weight and clinical observations were recorded. The tested dose was based on dose-range finding study and 100% test material was found to be the highest non-irritating concentration.

There were no deaths, test substance-related clinical signs of toxicity or changes in body weight. No skin sensitisation potential was recorded in any of the animals.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate does not require classification as a skin sensitiser according to Regulation 1272/2008.