Registration Dossier
Registration Dossier
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EC number: 701-027-7 | 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:
TAME was considered not sensitising in a guinea pig Bühler test performed according to USEPA Toxic Substance Control Act specification and under GLP (Pharmaco LSR, 1995). The incidence index in the positive control animals was 100%. None of the animals induced and challenged with TAME showed a dermal response, the incidence index and severity score being zero.
Migrated from Short description of key information:
Not a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
Respiratory tract sensitisation is not expected as no positive human data are available suggesting that TAME causes respiratory tract sensitisation. In addition, no inflammatory changes indicative of respiratory tract sensitisation were reported in repeated exposure inhalation studies in animals.
Justification for classification or non-classification
Based on the available data, TAME is not a skin or respiratory tract sensitiser. In accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.
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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