Registration Dossier
Registration Dossier
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EC number: 262-110-7 | CAS number: 60223-95-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP study with limited details on the method used. All information in the report is reflected in this summary
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Hazardous Substances Act (1973)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dinonylnaphthalenedisulphonic acid
- EC Number:
- 262-110-7
- EC Name:
- Dinonylnaphthalenedisulphonic acid
- Cas Number:
- 60223-95-2
- Molecular formula:
- C28 H44 O6 S2
- IUPAC Name:
- dinonylnaphthalenedisulphonic acid
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Nacure 155
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: indicated to be from stock
- Age at study initiation: mature
- Weight at study initiation: no data
- Housing/diet/water: no data:
ENVIRONMENTAL CONDITIONS: no data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 55% - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: ca 6 cm2 (2 sites one abraded and one intact skin)
- Type of wrap if used: surgical gauze patch wrapped with rubber dam
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: FHSA, similar to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24-72
- Score:
- ca. 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- non-irritant
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is not irritating to the skin
- Executive summary:
The test substance was applied on the skin of 6 rabbits under occlusion for 24 hours. Very slight erythema and oedema were seen in 1 -2 rabbits at 24 h. All effects were fully recovered after 72 hours. The test substance is not irritating to the skin.
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