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Toxicological information

Skin irritation / corrosion

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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:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 12th May, 1981
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd.
- Age at study initiation: adult, age not specified.
- Weight at study initiation: 2.7 - 3.3 kg
- Housing: animals were maintained in individual wire cages type III.
- Diet: standard diet "ssniff K 4", ad libitum.
- Water: ad libitum.
- Health status: animals were routinely inspected for health status. The animal facilities were disinfected by Zephirol (1% in water), twice a week. About 1 day before the administration, the rabbits were examined in order to assess the suitability for use.
- Quarantine: 14 days in testing laboratories.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Relative humidity: 45 - 65 %
- Air changes: ca 10 per hr.
- Photoperiod: 12 hrs dark / hrs light.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
500 mg in water
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
Three rabbits
Details on study design:
TEST SITE
- Area of exposure: the day of the exposure, the skin rabbits was clipped on the flanks.. The shaven skin involves an area of ca 6 x 6 cm.
- Type of wrap if used: hypoallergenic gauze measuring ca 6 cm2, fixed by elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 4 hours

SCORING SYSTEM
Skin reacrions have been scored according to the Draize scale.

Evaluation of skin reactions
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema Formation
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
Irritation parameter:
edema score
Basis:
animal: 3/3
Time point:
24/48/72 h
Score:
< 2.3

Any other information on results incl. tables

Individual reaction

Animal N. Effect Reaction after
1 h 24 hrs 48 hrs 72 hrs 7 d
T92 Erythema 0 0 0 0 0
Oedema 0 0 0 0 0
T83 Erythema 0 0 0 0 0
Oedema 0 0 0 0 0
T75 Erythema 0 0 0 0 0
Oedema 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not skin irritant
Executive summary:

The study was performed to assess the irritation of the test material to the skin of the New Zealand White rabbit. The method followed OECD Guidelines No. 404.

A single 4-hour semi-occluded application (0.5 g in water) of the test material was administered to the intact skin of three rabbits. Skin reactions were recorded 1, 24, 48, 72 hours and at 7 days after administration.

Skin reactions were recorded in none of the treated animals.

Conclusion

The 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.