Registration Dossier
Registration Dossier
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EC number: 276-677-3 | CAS number: 72479-30-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From June 25, 1981 to August 6, 1981 to
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: "The Code of Federal Regulations Title 16, Section 1500.41"
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Acid Brown 098
- IUPAC Name:
- Acid Brown 098
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: The test item was applied on intact and on abraded skin after shaving
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 3 male and 3 female rabbit
- Details on study design:
- TEST SITE
- Area of coverage: 2.5 x 2.5 cm
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #4, #5, #6
- Time point:
- other: mean score after 24 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No dermal effects observed
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean score after 24 and 72 hours
- Score:
- ca. 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- animal: all rabbits
- Time point:
- other: mean score after 24 and 72 hours
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- other: No dermal effects observed
- Remarks on result:
- other: intact skin
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to the CLP Regulation (EC n. 1272/2008)
- Conclusions:
- The substance is not irritating for skin rabbit
- Executive summary:
The substance has been tested for skin irritation according to the method inside "The Code of Federal Regulations Title 16, Section 1500.41" similar to OECD Guideline 404.
Six rabbits were tested with 0.5 g of test substance on shaved skin. After the application period of 24 hours and during the observation period of 24 and 72 hours only one rabbit shows a slight erythema, but fully reversible within 72 hours.
The substance is considered to be not irritant
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