Registration Dossier
Registration Dossier
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EC number: 944-003-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a GLP-compliant OECD 435 Guideline study, the test substance was determined to be corrosive to skin and classified as Category 1C (corrosive) based on GHS criteria and, given this result along with a known pH >11.5, the substance is presumed to also cause serious eye damage (Category 1) based on GHS criteria.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18-July-2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 500 uL
- Duration of treatment / exposure:
- Not applicable.
- Duration of post-treatment incubation (if applicable):
- Not applicable.
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Mean
- Value:
- 32.18
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: Standard Deviation
- Remarks:
- +/- 0.17
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Executive summary:
In a GLP-compliant OECD 435 Guideline study, the mean time for the test substance to penetrate the biobarrier was 32.18 minutes (+/- 0.17) and was therefore determined to be corrosive to skin and classified as Category 1C (corrosive) based on GHS criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In an OECD 435 Guideline Study, the test substance was determined to be corrosive to skin and classified as Category 1C (corrosive) based on GHS criteria and, given this result along with a known pH >11.5, the substance is presumed to also cause serious eye damage (Category 1) based on GHS criteria.
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.
