Registration Dossier

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:
1985-11-23 to 1985-12-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study; in deviation from OECD TG 404 occlusive dressing was used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Yellowish liquid, high viscosity
Content: 100%

Test animals

Species:
rabbit
Strain:
other: Small white Russian, Chbb-SPF
Details on test animals and environmental conditions:
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.7 kg
- Environmental conditions:
room temperature: 20°C (+/- 1°C);
humidity: 60% (+/- 5%);
Air change: 15 times/hour;
Light: 12 hour light/dark rhythm;
feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
water: tap water ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL test item
Duration of treatment / exposure:
4 hour(s)
Observation period:
- Post exposure observation period: 8 days
- Observations at 1, 24, 48, 72 hours, 6, 9, 12 and 14 days after administration of the test substance
Number of animals:
3 males, 3 females
Details on study design:
- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1; 24; 48; 72 h
Score:
1.67
Max. score:
8
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0.39
Max. score:
4
Reversibility:
fully reversible within: 6 days
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 1.33
- Edema: 0.39
- Irritation index: 1.67/8
Other effects:
no further information

Any other information on results incl. tables

To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales. For details see attached table.

Applicant's summary and conclusion

Conclusions:
According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.
Executive summary:

To test the acute skin irritant effect of the test item was applied to the shaven dorsal skin of rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

To a male rabbit, all animals showed erythema and 2 animals oedema after one hour. At 24 hours 1 male rabbit showed erythema grade 3, 2 female erythema grade 2 and 2 male/ 1 female erythema grade 1. Only 1 male and 1 female showed oedema. At 48 hours up to 1 male rabbit, all showed erythema and one male oedema. At 72 hours 1 male and 2 female showed erythema. At 6 days 1 male and 2 female showed formations of scales.

According to the study, the test item showed a slight irritant effect on the skin of male and female rabbits.