Registration Dossier
Registration Dossier
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EC number: 212-379-1 | CAS number: 812-00-0
Endpoint summary
Administrative data
Description of key information
Skin corrosion/irritation in vivo: The test item was determined to be corrosive to rabbit skin (OECD 404).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- albino
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin served as control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- Three
- Remarks on result:
- other: severe dermal reactions with necrosis in all three animals
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Severe dermal irritation with necrosis were reported for all three animals tested.
- Executive summary:
A single semi-occlusive application of the test item to intact rabbit skin for four hours elicited severe dermal irritation with necrosis.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin corrosion in vitro
The study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to skin or irritating to eyes.
Skin irritation in vitro
An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available.
Justification for classification or non-classification
Available data from an in vivo study indicates that the substance is corrosive to skin under the terms of Regulation (EC) 2072/2008.
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.
