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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
See attached justification
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981, 1992
Deviations:
yes
Remarks:
Observation period 7 days instead of 14 days
GLP compliance:
yes
Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
No data
Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume): 0.5 ml
- Concentration (if solution): 100 %
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
Test 1: 3
Test 2 and 3: 4
Details on study design:
TEST SITE
- Area of exposure: flank
- % coverage: no data
- Type of wrap if used: semi-occlusive patches (multi-patch)

OBSERVATION TIME POINTS
1 hour and 1, 2, 3 and 7 days

SCORING SYSTEM: Draize scale, following OECD Test Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Marked and slight desquamation from skin surface appeared as follows:
- Test 1: at day 2, 3 and 7 (1 animal marked)
- Test 2: at day 1, 2, 3 and 7 (2 animals marked, 1 animal slight)
- Test 3: at day 3 and 7 (1 animal marked, 3 animals slight)
Other effects:
No data

Mean values (24 -72h) per animal per endpoint per test (used for CLP classification):

Irritation parameter Basis Time point Score Reversibility Remarks
Erythema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Oedema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Oedema score Animal #2 24-72 hrs 1.3 Not fully reversible within: 7 days Test 1
Erythema score Animal #3 24-72 hrs 1.7 Fully revesible within: 7 days Test 1
Oedema score Animal #3 24-72 hrs 1 Not fully reversible within: 7 days Test 1
Erythema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #1 24-72 hrs 1.7 Not fully reversible within: 7 days Test 2
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #2 24-72 hrs 1.7 Fully revesible within: 7 days Test 2
Erythema score Animal #3 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #3 24-72 hrs 1 Not fully reversible within: 7 days Test 2
Erythema score Animal #4 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #4 24-72 hrs 1 Not fully reversible within: 7 days Test 2
Erythema score Animal #1 24-72 hrs 1 Fully revesible within: 7 days Test 3
Oedema score Animal #1 24-72 hrs 0 - Test 3
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 3
Oedema score Animal #2 24-72 hrs 1 Fully revesible within: 7 days Test 3
Erythema score Animal #3 24-72 hrs 2 Fully revesible within: 7 days Test 3
Oedema score Animal #3 24-72 hrs 0.7 Fully revesible within: 7 days Test 3
Erythema score Animal #4 24-72 hrs 1.7 Fully revesible within: 7 days Test 3
Oedema score Animal #4 24-72 hrs 0 - Test 3
Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
Under the conditions of this study, mean erythema and edema scores in the animals in each test were not above 2.3 for the timepoints concerned for classification. However, some effects did not disappear within the 7 days observation period. Therefore the substance is considered to be irritating to skin and should be classified as such based on the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

Single 4-hour-exposure of  Linalool (100% concentration) under semi-occlusive conditions in three independent experiments caused slight irritation on rabbit skin. A mean erythema score (24-72h) of at least 2 for at least 24 hours was observed in rabbits one of the three tests. Mean erythema values (24-72h) for each of the animals showed a maximum of 2 in all three tests. Erythema was still visible after 7 days. In addition desquamation was noted. Mean oedema scores were (24-72h) <1.4. Mean oedema values (24 -72h) for each of the animals showed a maximum of 1.7 in all three tests. Marked and slight desquamation from skin surface appeared at day 1, 2, 3, and 7 days. The skin responses (erythema and/or oedema) did not disappear in all animals after 7 days. Based on these data linalool is considered to be irritating to the rabbit skin. The substance needs to be classified as skin irritant according to the criteria outlined in Annex I of Regulation (EC)1272/2008.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.9
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 1
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 2
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Test 3
Irritant / corrosive response data:
Marked and slight desquamation from skin surface appeared as follows:
- Test 1: at day 2, 3 and 7 (1 animal marked)
- Test 2: at day 1, 2, 3 and 7 (2 animals marked, 1 animal slight)
- Test 3: at day 3 and 7 (1 animal marked, 3 animals slight)
Other effects:
No data

Any other information on results incl. tables

Mean values (24 -72h) per animal per endpoint per test (used for CLP classification):

Irritation parameter Basis Time point Score Reversibility Remarks
Erythema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Oedema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 1
Oedema score Animal #2 24-72 hrs 1.3 Not fully reversible within: 7 days Test 1
Erythema score Animal #3 24-72 hrs 1.7 Fully revesible within: 7 days Test 1
Oedema score Animal #3 24-72 hrs 1 Not fully reversible within: 7 days Test 1
Erythema score Animal #1 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #1 24-72 hrs 1.7 Not fully reversible within: 7 days Test 2
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #2 24-72 hrs 1.7 Fully revesible within: 7 days Test 2
Erythema score Animal #3 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #3 24-72 hrs 1 Not fully reversible within: 7 days Test 2
Erythema score Animal #4 24-72 hrs 2 Not fully reversible within: 7 days Test 2
Oedema score Animal #4 24-72 hrs 1 Not fully reversible within: 7 days Test 2
Erythema score Animal #1 24-72 hrs 1 Fully revesible within: 7 days Test 3
Oedema score Animal #1 24-72 hrs 0 - Test 3
Erythema score Animal #2 24-72 hrs 2 Not fully reversible within: 7 days Test 3
Oedema score Animal #2 24-72 hrs 1 Fully revesible within: 7 days Test 3
Erythema score Animal #3 24-72 hrs 2 Fully revesible within: 7 days Test 3
Oedema score Animal #3 24-72 hrs 0.7 Fully revesible within: 7 days Test 3
Erythema score Animal #4 24-72 hrs 1.7 Fully revesible within: 7 days Test 3
Oedema score Animal #4 24-72 hrs 0 - Test 3

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
Under the conditions of this study, mean erythema and edema scores in the animals in each test were not above 2.3 for the timepoints concerned for classification. However, some effects did not disappear within the 7 days observation period. Therefore the substance is considered to be irritating to skin and should be classified as such based on the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC). This result was used for read-across to tetrahydrolinalyl acetate.
Executive summary:

Single 4-hour-exposure of  Linalool (100% concentration) under semi-occlusive conditions in three independent experiments caused slight irritation on rabbit skin. A mean erythema score (24-72h) of at least 2 for at least 24 hours was observed in rabbits one of the three tests. Mean erythema values (24-72h) for each of the animals showed a maximum of 2 in all three tests. Erythema was still visible after 7 days. In addition desquamation was noted. Mean oedema scores were (24-72h) <1.4. Mean oedema values (24 -72h) for each of the animals showed a maximum of 1.7 in all three tests. Marked and slight desquamation from skin surface appeared at day 1, 2, 3, and 7 days. The skin responses (erythema and/or oedema) did not disappear in all animals after 7 days. Based on these data linalool is considered to be irritating to the rabbit skin. The substance needs to be classified as skin irritant according to the criteria outlined in Annex I of Regulation (EC)1272/2008. This result was used for read-across to tetrahydrolinalyl acetate.