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EC number: 211-199-0 | CAS number: 633-96-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965)
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- EC Number:
- 211-199-0
- EC Name:
- Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
- Cas Number:
- 633-96-5
- Molecular formula:
- C16H12N2O4S.Na
- IUPAC Name:
- sodium;4-[(2E)-2-(2-oxonaphthalen-1-ylidene)hydrazinyl]benzenesulfonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Californian
- Details on test animals or test system and environmental conditions:
- Age: 12-16 weeks
Body weight: average 2.16 kg for males and 2.24 for females.
Source: Hylyne Commercial rabbits Lt
Acclimation: 1 week
Caged singly in an experimental room mainteined at a temperature of 16°C and with a humidity of 50-70%.
Animals were exposed to artificial light for 10 hours daily from 8-18 hours.
Commercial diet, Labsure Christopher Hill Group, was fed ad libitum.
Sterile filtered water was available at all the times.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- 10 g of the test compound was mixed with 12ml of deionised water to make a solution of 20ml.
1 ml of which was applied to each test site on a 2.5cm square gauze pad.
These were couered with aluminium foil secured with "TFanspore" surgical tape. The test sites were then couered by a 6" wide "Coban" self adhesive bandage in order to retain the test substance in close contact with the skin. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours and up to 14 days after treatment
- Number of animals:
- 6, 3 for each sex
- Details on study design:
- Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10%
of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application
of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep
to penetrate the stratum corneum but not to damage the dermis. The left hand sit« remained intact.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 11,12
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal: 13, 15,14 and 16
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 11
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 15,12 and 14
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal: 16
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the test results, the tested item is to be considered as non-irritant to the skin of rabbits.
- Executive summary:
The primary irritation score was assessed following the Hazardous Substances Regulation, US Federal Hazardous Labelling Act. Sect. 191-11 (February 1965).
The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin under CLP classification.
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