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:
from 1982-03-08 to 1982-04-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
dorsal surface clipped 3-4 days before the test started instead of 24 h before start of test as indicated in the guideline. No information on the housing is given. No data about reversibility of effects.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9-12 weeks

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped 3-4 days before start of test. Animals in the telogen phase of hair growth used in the test.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
immediately after treatment, at 24, 48 and 72 h
Number of animals:
8
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm square
- Type of wrap if used: zinc oxide plaster

REMOVAL OF TEST SUBSTANCE
- Washing: wiped clean of excess material
- Time after start of exposure: 4 h

SCORING SYSTEM: from 0 to 4 (maximum possible)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The substance was irritant to rabbits in a covered patch skin irritation test. According to CLP, this substance is considered as irritating to the skin and is classified into skin irritation Category 2.
Executive summary:

3,5,5-trimethylhexyl acetate was tested in a non-GLP study slightly deviating from OECD TG 404 "covered patch skin irritation test". Eight New Zealand White rabbits were exposed to the undiluted test item for 4 hours under individual semi-occlusive patches. The irritation reactions were assessed immediately after removal of the patch and after 24, 48 and 72 hours. The mean values of erythema score at 24, 48 and 72 hours were between 2.3 and 3.7 in all tested animals. According to the CLP Regulation, this test item should be classified as a skin irritant, Category 2.