Registration Dossier
Registration Dossier
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EC number: 211-309-7 | CAS number: 637-92-3
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:
One study with guinea pigs, performed according to OECD Guideline 406 and under GLP (Pharmakon Europe, 1994d), was available for assessment. Female guinea pigs were induced intradermally with 10% ETBE. For topical application (under occlusion, 48 hours) undiluted ETBE was applied to the injection site. For challenge, occlusive epicutaneous application of 100% ETBE for 24 hours was used. Visual examination of the challenge site (24 and 48 hours after the challenge) revealed no evidence of any redness or oedema in any of the control (liquid paraffin) or test animals. ETBE did not cause skin sensitisation in this study.
Migrated from Short description of key information:
ETBE did not provoke any sign of skin sensitisation in the guinea pig. Based on this result, ETBE is not considered a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
No information available. However, respiratory tract sensitisation is not expected as no positive human data are available suggesting that ETBE has any potential to cause respiratory tract sensitisation. In addition, there is no evidence of respiratory tract effects reported in repeated exposure inhalation studies in animals.
Justification for classification or non-classification
ETBE is not considered a sensitiser. In accordance to 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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