Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid

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.