Registration Dossier
Registration Dossier
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EC number: 200-291-6 | CAS number: 56-84-8
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 skin sensitisation potential of L-aspartic acid using the guineapig. The method followed was that described in: EEC Methods for the determination of toxicity, Annex of Directive 92169/EEC (OJ No: L383A, 29.12.92), Part B, Method B.6. Acute toxicity (skin sensitisation). Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected: Intradermal injection: 0.01 % w/v in water for irrigation Topical application: 70 % w Iv in distilled water Challenge application: 70 and 35% w/v in distilled water Ten test and five control guinea-pigs were used in this study. In this study L-aspartic acid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals. L-aspartic acid does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Council Directive 79/8311EEC Annex VI, Part II(D) as described in The Commission Directive 93/211EEC.
Migrated from Short description of key information:
A study was performed to assess the skin sensitisation potential of L-aspartic acid using the guineapig. The method followed was that described in: EEC Methods for the determination of toxicity, Annex of Directive 92169/EEC (OJ No: L383A, 29.12.92), Part B, Method B.6. Acute toxicity (skin sensitisation). Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected: Intradermal injection: 0.01 % w/v in water for irrigation Topical application: 70 % w Iv in distilled water Challenge application: 70 and 35% w/v in distilled water Ten test and five control guinea-pigs were used in this study. In this study L-aspartic acid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals. L-aspartic acid does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Council Directive 79/8311EEC Annex VI, Part II(D) as described in The Commission Directive 93/211EEC.
Justification for classification or non-classification
A study was performed to assess the skin sensitisation potential of L-aspartic acid using the guineapig. The method followed was that described in: EEC Methods for the determination of toxicity, Annex of Directive 92169/EEC (OJ No: L383A, 29.12.92), Part B, Method B.6. Acute toxicity (skin sensitisation). Based on the results of a preliminary study and in compliance with the guideline, the following dose levels were selected: Intradermal injection: 0.01 % w/v in water for irrigation Topical application: 70 % w Iv in distilled water Challenge application: 70 and 35% w/v in distilled water Ten test and five control guinea-pigs were used in this study. In this study L-aspartic acid did not produce evidence of skin sensitisation (delayed contact hypersensitivity) in any of the test animals. L-aspartic acid does not require labelling with the risk phrase R43 "May cause sensitization by skin contact" in accordance with Council Directive 79/8311EEC Annex VI, Part II(D) as described in The Commission Directive 93/211EEC.
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