Registration Dossier
Registration Dossier
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EC number: 200-291-6 | CAS number: 56-84-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
An OECD validated 471 study was perfromed on L'Apartic acid. The 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.
Short description of key information:
An OECD validated 471 study was perfromed on L'Apartic acid. The 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.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
An OECD validated 471 study was perfromed on L'Apartic acid. The 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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