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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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Test conducted prior to the GLP guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
other: FDA of the United States
Version / remarks:
FDA of the United States (Fed. Reg .28 (119), 5582 1963)
Qualifier:
according to guideline
Guideline:
other: Draize and Kelley
Version / remarks:
Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36)
GLP compliance:
no
Remarks:
Test conducted priro to the GLP guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-dimethyloct-7-en-2-yl acetate
EC Number:
258-751-7
EC Name:
2,6-dimethyloct-7-en-2-yl acetate
Cas Number:
53767-93-4
Molecular formula:
C12H22O2
IUPAC Name:
2,6-dimethyloct-7-en-2-yl acetate
Test material form:
liquid
Specific details on test material used for the study:
Clear colorless liquid designed Dihydromyrcenylacetate (Institute's code: DHMA) was received on 19th Januray, 1979.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Twelve healthy adult albino rabbits are used

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of undiluted the test substance is brought on the skin
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
Six rabbits are treated on the intact skin and Six others on the abraded skin

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, also animal 8959 and 8960
Remarks:
24 and 72 hours were scored
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, also animal 8961
Remarks:
24 and 72 hours were scored
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 1 animal
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 5 animals; 5857, 8959, 8960, and 8961
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: intact skin, 1 animal
Remarks:
24 and 72 hours were scored
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: 1 animal
Remarks:
24 and 72 hours were scored

Any other information on results incl. tables

After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema.

After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness.

There were no disctinct differences between reactions of the intact and those of the abraded skin. From these results it appear that DHMA is a moderate primary skin irritant.

Applicant's summary and conclusion

Interpretation of results:
other: Not a skin irritant.
Remarks:
According to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The substance is not a skin irritant in the OECD TG 404 using EU CLP criteria, but it is classified Category 3 (mild irritant) based on GHS criteria.
Executive summary:

The substance was examined for primary skin irritation according to the Draize and Kelley (Drug Cosmet. Industr. 71 (1952) 36) and FDA of the United States (Fed. Reg .28 (119), 5582 1963) methods somewhat similar to OECD TG 404. Six rabbits, previously clipped on the backs, are treated on the intact skin and Six others on the abraded skin with 0.5 ml of the undiluted test material. After an exposure of 24 hours the patches and the material applied are removed and the resulting skin reactions are evaluated by the method of Draize. A second reading is made 48 hours later (72 hours application). After 24 hours the skin reactions observed generally consisted of very slight or well-defined erythema and very slight or slight oedema. After 72 hours the skin reactions generally consisted of well defined erythema, very slight oedema and distinct scaliness. There were no disctinct differences between reactions of the intact and those of the abraded skin.

From the results of the present study it can be concluded that the substance irritation seen is insufficient for being a skin irritant.