Registration Dossier
Registration Dossier
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EC number: 217-440-6 | CAS number: 1852-04-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1989-02-14 to 1989-02-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A well documented study according to OECD guideline but not GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dodecanedioic acid
- EC Number:
- 211-746-3
- EC Name:
- Dodecanedioic acid
- Cas Number:
- 693-23-2
- Molecular formula:
- C12H22O4
- IUPAC Name:
- dodecanedioic acid
- Details on test material:
- Dodecanedioic acid of Hüls AG, purity ca. 99 %; impurities: homologous dicarboxylic acids, total 1 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: small white russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male
- Weight at study initiation: 2.2 - 2.4 kg
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Amount / concentration applied:
- Concentration: 50 %
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 0.5 g ground in mortar, wetted with 0.5 ml deionized water
- Area of exposure: 6 cm2
- Occlusion: mull patch, elastic dressing - Removal of test substance: washing with warm water - Post exposure period: 6 days - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 6 days
- Number of animals:
- 3
- Details on study design:
- EXAMINATIONS
- Examination time points: 1, 24, 48, 72 hours, and 6 days after patch removal; evaluation based on readings 1-4
- Scoring system: OECD Guideline; evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1h, 24h, 48h,72h, 6 days
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 0.0
- Edema: 0.0
REVERSIBILITY: not applicable - Other effects:
- No reaction was observed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
- Conclusions:
- Based on a read across (category approach), no classification regarding the skin irritation is required for undecanedioic acid.
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