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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
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:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
24 hour occlusive exposure with observations at 24 and 48 hours after start of exposure.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate
EC Number:
907-870-9
Molecular formula:
Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
IUPAC Name:
Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate
Test material form:
liquid
Details on test material:
Mix of Diisobutyl esters:
34% Diisobutyl succinate
55% Diisobutyl glutarate
11% diisobutyl adipate

Overall purity 99.94%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of the pure substance
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
6 (male)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.83
Max. score:
2
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0.33
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0.17
Max. score:
1
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Erythema:
At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction
At 48 hours 4 animals had no reaction and 2 animals had a slight reaction

Edema
At 24 hours 1 animal had a slight reaction and 5 had no reaction
At 48 hours no animals had reactions.

This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.

Any other information on results incl. tables

Erythema:

At 24 hours 2 animals had no reaction, 3 had a slight reaction and 1 had a mild reaction

At 48 hours 4 animals had no reaction and 2 animals had a slight reaction

Edema

At 24 hours 1 animal had a slight reaction and 5 had no reaction

At 48 hours no animals had reactions.

This substance therefore produced minimal irritation in 6 animals after a very conservative 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
This substance produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.
Executive summary:

Doses of 0.1ml of test compound applied to intact skin of rabbits under 1 1/2 inch by 1 1/2 inch, 12 -ply gauze squares. Rubber sheeting was then loosely wrapped around the trunk and secured with tape. After 24 hours the rabbits were removed from the stocks, the patches taken off and the reactions observed. Observations were also made at 48 hours. Erythema and edema were scored qualitatively as negative, slight, mild, moderate or severe.

This substance  produced minimal irritation in 6 animals after a 24 hour occlusive exposure. As such it is not considered an irritant according to the EU classification and labelling criteria.

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