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Registration Dossier
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EC number: 217-707-7 | CAS number: 1937-19-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- study conducted on the analogue substance; The Reliability of the Source Study is 2.
- Justification for type of information:
- The read across justification is detailed in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: US Department of Agriculture (Fed Reg 38, 187, 27019, 1973)
- Principles of method if other than guideline:
- In order to evaluate the primary skin irritation of the substance, a single dose was tested on the skin of six rabbits. The test item was applied to intact and wound skin of each animal. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
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: 3-4 kg
- Housing: singly
- Diet ad libitum
- Water ad libitum
standard conditions
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shorn: intact and scarificed
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- According to the US Department of Agriculture (Fed Reg. 38, 187, 27019, 1973).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: all six
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: all six
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation effects were observed
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) No. 1272/2008
- Conclusions:
- The test item was found to be not irritating to rabbit skin.
- Executive summary:
The test item was investigated for skin irritating property in rabbits using a guideline given by the U.S. Department of Agriculture (Fed. Reg 38, 187, 27019, 1973). A single dose was tested on the skin of six rabbits. The test item was applied to intact and wound skin of each animal. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.
The test item caused no irritation in the skin of rabbits.
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