Registration Dossier
Registration Dossier
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EC number: 218-147-6 | CAS number: 2052-49-5
Endpoint summary
Administrative data
Description of key information
In accordance with ANNEX VII colum 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5). The experimental pH of the test chemical was 14. Hence, based on the high pH of the test chemical, the in vivo and in vitro sensitization studies were considered for waiver.
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:
- the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is a strong acid (pH ≤2.0) or base (pH =>11.5)
- the study does not need to be conducted because the substance is classified as skin corrosion (Category 1, 1A, 1B or 1C)
- Executive summary:
The study need not be conducted because the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5).The experimental pH of Tetrabutylammonium hydroxide was 14.Hence this endpoint skin sensitization was considered for waiver.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In accordance with ANNEX VII colum 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5)
The experimental pH of the test chemical was 14. Hence, based on the high pH of the test chemical, the in vivo and in vitro studies were considered for waiver.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008) and based on the high pH (pH= 14) of the test chemical, the classification Skin Sensitizer 1 is proposed for the test chemical
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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