Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
Data available on analogs of Dermalcare MAP L213/S satisfy the skin sensitisation endpoint requirements for an Annex VII dossier based on a weight of evidence approach. All the data available show clearly negative results. The studies are screening tests but are scientifically acceptable and of good quality.
Migrated from Short description of key information:
Guinea Pig Maximisation tests are available on two analogs of Dermalcare MAP L213/S (i.e Dermalcare MAP L-213/K and Dermalcare MAP L-210). Both tests give negative results.
The Cosmetic Ingredient Review (CIR) published in 1983 provided an assessment on sodium laureth sulfate, another analog of Dermalcare MAP L213/S. Sodium laureth sulfate appeared to be a non sensitiser in a Buehler test on guinea pigs.
Justification for selection of skin sensitisation endpoint:
Weight of evidence approach based on several data available for structural analogs of Dermalcare MAP L213/S (for justification of read-across between Dermalcare MAP L213S and its analogues, please refer to corresponding assessment report in Section 13).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP2.
Self classification:
Dermalcare MAP L213/S is not classified for skin sensitisation according to Regulation (EC) 1272/2008 (CLP) and to Directive 67/548/EEC.
No classification for the respiratory sensitisation is proposed due to a lack of data.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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