Registration Dossier
Registration Dossier
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EC number: 201-134-4 | CAS number: 78-70-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981, 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Linalool
- Analytical purity: 97.1%
- Lot/batch No.: confidential
- Stability under test conditions: stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- No data
Test system
- 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 applied: 0.5 mL
- Concentration: 100 % - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 1, 2, 3, and 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: Semi-occlusive patches (multi-patch)
SCORING SYSTEM: Draize scale, following OECD Test Guideline 404 (Erythema and Eschar formation / Oedema formation). Maximum possible score: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 3
- 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:
- positive indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- 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:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- 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:
- positive indication of irritation
- Remarks:
- Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Remarks:
- Test 1
- 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:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- This interpreation was based on a mean erythema score (24-72h) of at least 2 for at least 24 hours was observed in rabbits in 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 it can be assumed that linalool is 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.
- 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 it can be assumed that linalool is 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.
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