Registration Dossier
Registration Dossier
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EC number: 255-272-5 | CAS number: 41233-93-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Additional information
For potassium 2-methylbutan-2-olate no data are available on the effects on fertility and on development toxicity and teratogenicity. The test substance is used as transported intermediate in a closed system. According to the REACh regulation (EC) No 1907/2006, Article 18.2 further testing is not required for this tonnage band. According to Annex VIII 8.7.1 a screening study does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI section 3.
Under strictly controlled conditions repeated exposure of workers is not expected. Due to the corrosive nature of the test substance, is it unlikely that repeated human exposure occurs under normal handling and use conditions.
Furthermore, the test substance is classified as corrosive to skin according to the CLP regulation (EC) No 1272/2008. In vivo testing with corrosive substances at concentrations causing corrosivity shall be avoided, as pointed out in the introductions to Annexes VII-X of the REACh Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The test substance hydrolyses rapidly in the presence of water. Therefore, the hydrolysis products are considered to be relevant for classification according to CLP regulation (EC) No 1272 /2008.
For the hydrolysis products potassium hydroxide (CAS No. 1310-58-3) and 2 -methylbutan-2 -ol (CAS No. 75-85-4) disseminated dossiers are available on the homepage of ECHA. Both substances are not classified for reproduction toxicity according to CLP regulation Annex VI and according to the self-classification included in the disseminated dossiers. Based on this, also the test substance should not be classified as toxic for reproduction according to CLP regulation.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
