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Registration Dossier
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EC number: 701-188-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-01-16 to 2006-02-23
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- GLP followed OECD, well conducted and documented study, substance details and certificate of analysis. However there are deviations: slight higher temperature, longer rest phase between induction and challenge, and insufficient number of test animals.
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 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- slight higher temperature, longer rest phase between induction and challenge and insufficient number of test animals
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A study conducted according to Guideline OECD 406 before 2008 and is available on the registered substance.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre de Production Animale, Olivet, France
- Weight at study initiation: between 359 g and 500 g
-housing: housed in groups of 2 or 3 in makrolon containers
-diet(ad libitum): pelleted guinea pig breeding diet, ad libitum
- Water (e.g. ad libitum): tap water from public distribution system, ad libitum
- Acclimatation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): between 20 and 25
- Humidity (%): between 30 and 49
-air changes: at least 10 cycles per hour
-photoperiod: 12 hours dark / 12 hours light
IN-LIFE DATES: From: 2006-01-16 To: 2006-02-23
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- For maximal non necrotising concentration test (through intradermal injections): 100, 50, 25, 12.5, 6.25 and 3.125%
For maximal non irritant concentration (topical application): - Induction phase 100, 50,25, and 12.5% - Challenge 25, 12.5, 6.25 and 3.125%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- For maximal non necrotising concentration test (through intradermal injections): 100, 50, 25, 12.5, 6.25 and 3.125%
For maximal non irritant concentration (topical application): - Induction phase 100, 50,25, and 12.5% - Challenge 25, 12.5, 6.25 and 3.125%
- No. of animals per dose:
- For maximal non necrotising concentration test: 2 males
For maximal non irritant concentration: - Induction phase: 2 males
- Challenge phase: 1 male and 2 females - Details on study design:
- RANGE FINDING TESTS: For maximal non necrotising concentration test (through intradermal injections): 100, 50, 25, 12.5, 6.25 and 3.125% (2 males)
For maximal non irritant concentration (topical application): - Induction phase 100, 50,25, and 12.5% (2 males) - Challenge 25, 12.5, 6.25 and 3.125% (1 male and 2 females)
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intradermal injections in treated group and 3 pairs of intradermal injections in control group on day 0 and 2nd induction topical application in both treated and control groups on 7th day
- Exposure period: 9 days
- Test groups: 10 males
- Control group: 5 males
- Site: inter scapular zone
- Frequency of applications: only once
- Concentrations:
- Intradermal injections: 2 intradermal injections of the test item diluted at 6.25 % in olive oil. 2 intradermal injections of Freund's Complete Adjuvant diluted at 50 % in a physiological saline solution. 2 intradermal injections of a mixture with equal volumes of Freund's Complete Adjuvant at 50% and the test item diluted at 12.5% in olive oil.
- Topical application: on the same zone, with the test item at 100%
B. CHALLENGE EXPOSURE
- No. of exposures: one time
- Day(s) of challenge: 2
- Exposure period: 24 h
- Test groups: 10 males
- Control group: 5 males
- Site: dorso-lombar zone
- Concentrations: for group 1 and 2 topical application under occlusive dressing at the following concentrations: 25 and 12.5 %
- Evaluation (hr after challenge): skin reactions at 24 and 48 h - Challenge controls:
- 5 males, topical application under occlusive dressing at the following concentrations: 25 and 12.5%
- Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde (CAS No 101-86-0) and 2-mercaptobenzothiazole (CAS No 149-30-4)
Results and discussion
- Positive control results:
- The test substances Hexylcinnamaldehyde (50, 25 and 12.5%) and 2-Mercaptobenzothiazole (50 and 25%) were used as a positive control and induce positive sensitization response
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 45
- Total no. in group:
- 11
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 12.5%
- No. with + reactions:
- 18
- Total no. in group:
- 11
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 100
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 60
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No remarks
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Terpineol multiconstituent should not be classified according to CLP Regulation (EC) No 1272/2008.
- Executive summary:
In a skin sensitization study performed according to the OECD guideline 406 and conducted in compliance with GLP, Terpineol multiconstituent was tested in male albino guinea pigs using the Guinea pig Maximisation test method (10 treated animals and 5 control animals).
Preliminary studies were conducted to dertermine the maximal non necrotising concentration through intradermal injections and the maximal non irritant concentration by topical application. Six concentrations were tested for intradermal injections and for topical application: 100, 50, 25, 12.5, 6.25 and 3.125% in olive oil.
In the main experiment, the induction phase for the test group consisted of:
one pair of intradermal injections of test substance at 6.25% in olive oil
one pair of intradermal injections of Freund's complete adjuvant diluted 50% in physiological saline
one pair of intradermal injections of mixture of equal volumes of Freund's complete adjuvant at 50% and test substance at 12.5% in olive oil.
For control group, test substance was replaced by isotonic solution of NaCl.
Seven days later, undiluted test substance was applied topically for 48 h, followed by a rest phase of 17 days.
For the challenge phase, all animals were exposed to 25 and 12.5% of the test susbtance by topical application under occlusive conditions for 24 h. Cutaneous reactions were recorded 24 and 48 h after the removal of the test substance.
Hexylcinnamicaldehyde and mercaptobenzothiazole were used as positive controls and induced positive sensitization responses in test animals.
No cutaneous reactions following the removal of the occlusive dressing from all animals were observed at 24 and 48 h readings.
Terpineol multiconstituent can be considered as a non sensitiser and should not be classified according to CLP Regulation (EC) No 1272/2008.
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