Registration Dossier
Registration Dossier
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EC number: 276-675-2 | CAS number: 72479-28-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of Chemicals in Food, Drugs and Cosmetics (1959) of the US association AFDO
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- EC Number:
- 276-675-2
- EC Name:
- Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- Cas Number:
- 72479-28-8
- Molecular formula:
- C22H14Cl3N4NaO5S
- IUPAC Name:
- sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Age at study initiation: adult animals- Weight at study initiation: 1.3- 2.7 kg- Housing: single housing in V2A wire cages- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- not specified
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE- Area of exposure: 2.5 cm x 2.5 cm on back and flank- Type of wrap: plastic films of 5 x 5 cm fixed to the body with adhesive tape
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact skin. The primary irritaion index is 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not irritating to the rabbit skin.
- Executive summary:
The test item was tested for skin irritation and the test results showed a primary irritation index of 0 in all the trated animals.
The tested substance could be considered as a not skin irritant.
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