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Registration Dossier
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EC number: 701-188-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-01-17 to 2006-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study following OECD guidelines without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- EC Number:
- 232-081-5
- EC Name:
- (R)-α,α,4-trimethylcyclohex-3-ene-1-methanol
- Cas Number:
- 7785-53-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1R)-3-cyclohexene-1-methanol
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 233-986-8
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 10482-56-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- α,α-4-trimethyl-(1S)-3-cyclohexene-1-methanol
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- EC Number:
- 209-584-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexan-1-ol
- Cas Number:
- 586-81-2
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1-methyl-4-(1-methylethylidene)-cyclohexanol
- Reference substance name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Cas Number:
- 7299-41-4
- Molecular formula:
- C10H18O
- IUPAC Name:
- cis-4-isopropenyl-1-methylcyclohexanol
- Reference substance name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- EC Number:
- 209-585-9
- EC Name:
- 4-(isopropyl)-1-methylcyclohex-3-en-1-ol
- Cas Number:
- 586-82-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- 4-isopropyl-1-methyl-3-cyclohexen-1-ol
- Reference substance name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Cas Number:
- 27153-55-5
- Molecular formula:
- C13H24O
- IUPAC Name:
- 1-methyl-4-[1-1-(1-methylethoxy)ethyl]-cyclohexene
- Reference substance name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Cas Number:
- 7299-40-3
- Molecular formula:
- C10H18O
- IUPAC Name:
- trans-1-methyl-4-(1-methylethenyl)-cyclohexanol
- Reference substance name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 208-135-9
- EC Name:
- (1S-endo)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 512-13-0
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1S,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 2217-02-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,3,3-trimethyl-(1R,2R,4S)-bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- EC Number:
- 207-353-1
- EC Name:
- (1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol
- Cas Number:
- 464-45-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1S,2R,4S)- bicyclo[2.2.1]heptan-2-ol
- Reference substance name:
- (1R,2S,4R)-borneol
- EC Number:
- 207-352-6
- EC Name:
- (1R,2S,4R)-borneol
- Cas Number:
- 464-43-7
- Molecular formula:
- C10H18O
- IUPAC Name:
- 1,7,7-trimethyl-(1R,2S,4R)-bicyclo[2.2.1]heptan-2-ol
- Test material form:
- liquid
- Details on test material:
- Batch No.: 049807
Purity: 67.2% (sum of the three main constituents)
Name of test material (as cited in study report): TERPINEOL MULTICONSTITUENT
Physical state: colourless liquid
Storage conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry date: 30 November 2017
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
impurity 5
impurity 6
impurity 7
impurity 8
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gerome, Linxe, France
- Weight at study initiation: between 2.23 kg and 3.08 kg
- Housing: kept in individual box installed in conventional air conditioned
- Acclimation period: 5 days
- Diet (e.g. ad libitum): supplied from UAR 112, Villemoisson s/Orge, France, ad libitum
- Water (e.g. ad libitum): tap water from public distribution system, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 17 and 22
- Humidity (%): between 30 and 49
- Air changes (per hr): at least 10 cycles
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2006-01-17 To: 2006-02 13
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shorn by electric clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Type of wrap if used: strip of surgical adhesive tape
- Area of exposure: approximately 6 cm²
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
- Washing (if done): residual product is removed, if necessary, using a swab soaked in distilled water or a suitable solvent
SCORING SYSTEM:
Erythema and Eschar formation
0....No erythema
1....Very slight erythema
2....Well definite erythema
3....Moderate to severe erythema
4....Severe erythema (beef redness) with eschars formation preventing grading of erythema
Oedema
0......No oedema
1......Very slight oedema
2......Slight oedema (contour clearly defined)
3......Moderate oedema (raised approx. 1mm)
4......Severe oedema (raised more than 1 mm, and extended beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 5
- Irritant / corrosive response data:
- Application of the test substance Terpineol multiconstituent, was associated with a moderate erythema and a slight oedema 24 h after application. The reactions were totally reversible by the 6th day of the test. Skin recovered a normal aspect between the 11th and 14th day of the test.
- Other effects:
- Skin reactions such as dryness, slight dryness, scab, roughness/loss of lightness were observed from D2 to D12
Any other information on results incl. tables
Table 1: Individual and average scores after 4-hour exposure
OBSERVATIONS |
INDIVIDUAL DATA |
TOTAL OF INDIVIDUAL DATA |
||||||
Skin reactions |
Observation time |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
|
A 7158 |
Start : 2.64 |
A7181 |
Start : 2.23 |
A7182 |
Start : 2.43 |
|||
End : 3.08 |
End : 2.52 |
End : 2.88 |
||||||
Erythema and eschar |
24 h 48 h 72 h |
3 |
3 |
3 |
9 |
|||
3 |
3 |
3 |
9 |
|||||
3 |
2 |
2 |
7 |
|||||
Total |
9 8 |
8 |
||||||
Mean |
3.0 2.7 |
2.7 |
||||||
Oedema |
24 h |
2 |
2 |
2 |
6 |
|||
48 h |
2 |
2 |
2 |
6 |
||||
72 h |
2 |
1 |
1 |
4 |
||||
Total |
6 |
5 |
5 |
|
||||
Mean |
2.0 |
1.7 |
1.7 |
|
||||
Table 2: Individual skin reactions
OBSERVATIONS |
INDIVIDUAL DATA |
||||||
Skin reactions |
Observation time |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
A 7158 |
Start : 2.64 |
A7181 |
Start : 2.23 |
A7182 |
Start : 2.43 |
||
End : 3.08 |
End : 2.52 |
End : 2.88 |
|||||
Erythema and eschar |
1 h |
2 |
2 |
2 |
|||
24 h |
3 |
3 |
3 |
||||
48 h |
3 |
3 |
3 |
||||
72 h |
3 |
2 |
2 |
||||
Day 4 |
3 |
2 |
2 |
||||
Day 5 |
0 |
0 |
0 |
||||
Day 6 |
0 |
0 |
0 |
||||
Day 7 |
0 |
0 |
0 |
||||
Day 8 |
0 |
0 |
0 |
||||
Day 9 |
0 |
0 |
0 |
||||
Day 10 |
0 |
0 |
0 |
||||
Oedema formation |
1 h |
2 |
2 |
2 |
|||
24 h |
2 |
2 |
2 |
||||
48 h |
2 |
2 |
2 |
||||
72 h |
2 |
1 |
1 |
||||
Day 4 |
2 |
1 |
1 |
||||
Day 5 |
0 |
0 |
0 |
||||
Day 6 |
0 |
0 |
0 |
||||
Day 7 |
0 |
0 |
0 |
||||
Day 8 |
0 |
0 |
0 |
||||
Day 9 |
0 |
0 |
0 |
||||
Day 10 |
0 |
0 |
0 |
||||
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Conclusions:
- Terpineol multiconstituent should be classified as irritating to skin, in category 2 according to CLP regulation (EC) No 1272/2008.
- Executive summary:
A dermal irritation study was conducted according to OECD guideline 404 in compliance with GLP. Three healthy adult New Zealand white rabbits were exposed to 0.5 mL/rabbit of Terpineol multiconstituent on clipped skin of the dorsal area for 4 hours in semi-occlusive conditions. Skin reactions were observed at 1, 24, 48 and 72 h after removal of the substance until day 10. 1 hour after patch removal there was moderate erythema with slight oedema in all animals. Mean individual scores for 24, 48 and 72 h observation time points were 3, 2.7 and 2.7 for erythma and 2, 1.7 and 1.7 for oedema. The reactions were reversible within 5 days for all animals. The skin recovered a normal aspect between the 11th and the 14th day of the test.
Terpineol multiconstituent should be classified as irritant category 2 according to CLP Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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