Registration Dossier
Registration Dossier
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EC number: 262-110-7 | CAS number: 60223-95-2
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No study can be performed in view of the low pH of the substance. The results with the analogue salt are indicative for a non-sensitizing substance. This is confirmed by experience in handling the substance at the manufacturing site. The application of risk management measures to prevent contact with the corrosive substance are considered sufficient to prevent sensitization. Therefore no further investigations are considered necessary for this endpoint.
Migrated from Short description of key information:
A maximisation test in guinea pigs with the calcium salt of the analogue substance showed minimal sensitization. A test in humans however was clearly indicative of no sensitizing effects of the calcium salt of the analogue
Justification for selection of skin sensitisation endpoint:
a study is waived based on the pH of the substance
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the outcome of the human tests with the salt of the analogue, it is concluded that the substance is not sensitizing to the skin. No classification according to CLP (Regulation EC No 1272/2008) is considered necessary.
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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