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:

2 studies on the skin sensitising potential of AMP are available. In the first study Guinea pigs were treated topically with 0.5 mL of a 10% AMP solution; after 24 hours, sites were cleaned and scored for erythema and edema according to the method of Draize (Parekh, 1982a). At 48 hours, the application was repeated with each group, and continued 2-3 times per week until 10 applications were made. Animals were allowed a 2 week recovery period, and then challenged at a virgin site. Sites were scored again at 3 and 48 hours. Following challenge with 2.5% and 5% solutions of AMP, none of the animals exhibited a positive response.

In a second study of very similar design (0.05 mL of a 1% AMP solution for inductions, 0.1mL of 0.05% and 0.01% for challenge), guinea pigs were subjected to intradermal injections during the induction and challenge phases (Parekh, 1982b). During the induction phase, the first injection at 1% and second injection at 0.5% AMP induced necrotic lesions, so the remaining 8 injections were made with 0.1% solutions. At challenge with 0.05% and 0.01% AMP, one animal in the test group showed mild reactions with 0.05%. In a repeat challenge, none of the animals in the test group showed any reactions with AMP, so the material was considered to be non-sensitizing following intradermal application.

Conclusion

Two adequate skin sensitization tests have been conducted in guinea pigs, topically and intradermally. Results from both tests indicate that AMP has no sensitization potential.


Migrated from Short description of key information:
2 Guinea pig studies, one utilising topical inductionand challenge (Buehler method), the other using intradermal induction and challenge.

Respiratory sensitisation

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

Even though it is unclear whether skin sensitising potential can be extrapolated to respiratory sensitisation, considering the lack of skin sensitising potential it is unlikely that AMP would be a respiratory sensitiser.


Migrated from Short description of key information:
No data available other than skin sensitising data reported above.

Justification for classification or non-classification

Based on the negative studies available for AMP it does not meet the requirements for classification as a skin sensitising agent.