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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: experimental result on similar substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

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

Constituent 1
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-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate
Test material form:
solid: particulate/powder

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
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 Acid Orange 8 is to be considered as non-irritant to skin under CLP classification based on the result on similar substance.

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