Registration Dossier
Registration Dossier
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EC number: 266-936-9 | CAS number: 67701-12-6 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid zinc salt and SDA Reporting Number: 04-006-09.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Used in EU risk assessment for zinc oxide 2004, although not compliant with current guidlelines, considered reliable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- although not compliant with current guideline studies, considerd acceptable for assessment
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Zinc oxide
- EC Number:
- 215-222-5
- EC Name:
- Zinc oxide
- Cas Number:
- 1314-13-2
- Molecular formula:
- ZnO
- IUPAC Name:
- oxozinc
- Details on test material:
- no information
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no further information
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: ear
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 500 mg ZnO/animal
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 2
- Details on study design:
- no further information
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Irritant / corrosive response data:
- none
- Other effects:
- none
Any other information on results incl. tables
none
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of irritation observed.
- Executive summary:
In a skin irritation test, no dermal reactions were noted following the application of 500 mg ZnO/animal during 24 hours under occlusion.to the ears of 2 New-Zealand white rabbits. The observation period was for 7 days.
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