Registration Dossier
Registration Dossier
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EC number: 469-910-7 | CAS number: 847842-48-2
Endpoint summary
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:
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" (adopted 17 July 1992) and Method B6 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
Twenty test and ten control animals were used for the main study. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
Intradermal Induction: 10% w/v in arachis oil BP
Topical Induction: 50% w/w in arachis oil BP
Topical Challenge: 50% and 25% w/w in arachis oil BP
The test material produced a 0% (0/20) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
Migrated from Short description of key information:
The test material produced a 0% (0/20) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.
Justification for classification or non-classification
The sensitisation study has been carried out according to OECD and GLP Guidelines and can be considered to be reliable.
Although the study was carried out on an analogue material, the analogue is considered to be sufficiently similar to the substance of interest (please see attached data matrix and justification in Section 13 for additional details) for it to be used for the purposes of health and environment risk assessments.
Based on the sensitisation study the test material Abacavir Glutarate would not be classified as sensitising. However, it has been known to cause allergic skin reactions with repeated exposure to humans in the workplace. For this reason, classification as a Category 1 sensitiser is considered to be appropriate.
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