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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October from 19th to 26th, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid Yellow 218
IUPAC Name:
Acid Yellow 218

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.37 kg
- Housing: individually housed in suspended metal cages.
- Diet: free access to food (Rabbit Diet, Preston Farmers Limited, Nerv Leake, Boston, Lincolnshire, U.K. and Spillers Rabbit Diet, Daigety Agriculture Ltd., Almondsbury, Bristol) was allowed throughout the study.
- Water: free access to mains drinking water.
- Acclimation period: minimum acclimatisation period of five days.
- Health check: on the day before the test each of a group of rabbits was clipped free of fur from the dorsal/ flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Relative humidity: 47 - 65 %
- Air changes: approximately 15 changes per hour.
- Photoperiod: 12 hours light and 12 hours darkness.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 g of test material were moistened with 0.5 ml of distilled water
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
1 female and 2 males
Details on study design:
TEST SITE
- Area of exposure: test item was introduced under a 2.5 cm × 2.5 cm gauze patch and placed in position on the shorn skin.
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm × 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were examined. An additional observation was made on day 7 to assess the reversibility of the skin reactions.

SCORING SYSTEM
The test sites were examined for evidence of primary irritation and scored according to scale decribed in the Draize J.H. (1959), Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics".

Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar fornation (injuries in depth) 4

Oedema formatíon
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.
Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation.
Very slight oedema was noted at two treated skin sites one hour after patch removal.
All treated skin sites appeared normal at the 7-day observation.
The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.

Any other information on results incl. tables

Individual reactions

Animal  Reaction 1 hrs 24 hrs 48 hrs 72 hrs 7 days Mean 24/48/72 hrs
28 female Erythema/Eschar 1 STA 1 STA 1 STA 1 STA 0 1.00
39 male Erythema/Eschar 1 1 1 0 0 0.67
68 male Erythema/Eschar 1 STA 1 STA 1 STA 1 STA 0 1.00
28 female Oedema 1 0 0 0 0 0.00
39 male Oedema 0 0 0 0 0 0.00
68 male Oedema 1 0 0 0 0 0.00

STA: faint yellow-coloured staining caused by the material

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating
Executive summary:

The study was performed to assess the irritancy potential of the test material following a single, 4-hour, semi-occluded application to the intact rabbit skin. The method used followed OECD guideline 404.

Faint yellow-coloured staining caused by the test material was noted at two treated skin sites during the study. It did not affect evaluation of skin responses.

Very slight erythema was noted at all treated skin sites 1, 24 and 48 hours after patch removal and continued to be noted at two treated skin sites at the 72-hour observation. Very slight oedema was noted at two treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 7-day observation.

The test material produced a primary irritation index of 0.8 and was classified as a mild irritant to rabbit skin. No corrosive effects were noted.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.