Registration Dossier
Registration Dossier
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EC number: 272-657-3 | CAS number: 68901-15-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Feb - 02 Apr 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The test was done before LLNA as first-choice method for in-vivo testing was set into force.
Test material
- Reference substance name:
- Allyl (cyclohexyloxy)acetate
- EC Number:
- 272-657-3
- EC Name:
- Allyl (cyclohexyloxy)acetate
- Cas Number:
- 68901-15-5
- Molecular formula:
- C11H18O3
- IUPAC Name:
- allyl (cyclohexyloxy)acetate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 8 - 12 weeks
- Weight at study initiation: 338 - 426 g
- Housing: singly or in pairs in solid-floor polypropylene cages, bedding woodflakes
- Diet: Guinea Pig FD1 Diet (Special Services Limited, Witham, UK) ad libitum
- Water: mains tap water, ad libitum, analysis was performed
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Day 0 - 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/diethylphtalate 1:1
- Concentration / amount:
- 50% (v/v) and 100%
- Day(s)/duration:
- Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (controls), 20 (test groups)
- Details on study design:
- RANGE FINDING TESTS:
The concentrations of test material to be used at each stage of the main study were determined by sighting tests in which groups of guinea pigs were treated with various concentrations of test material. 4 animals were used: 2 animals for the topical induction and 2 for the topical challenge.
For the topical induction 2 animals were treated with 4 concentrations of the test item (10%, 25%, 50% and 100%). Applications were made to the clipped flanks under occlusive conditions for 6 h. The highest concentration of the test item producing only minimal dermal irritation was selected for the topical induction stage of the main study.
For the topical challenge 2 animals were treated with 2 concentrations of the test item (50% and 100%). Previously, the animals had been treated identically to the control animals of the main study an Days 0, 7 and 14. Applications were made to the clipped flanks under occlusive conditions for 6 h. The highest concentration of the test item which produced no evidence of dermal irritation, and 50% of the maximum non-irritant concentration were selected for the topical challenge stage of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: undiluted test substance
- Control group: a blank patch was applied
- Site: left flank
- Frequency of applications: every 7 days
- Duration: Days 0-14
- Concentrations: 100%, under occlusive conditions
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: test substance and test substance in ethanol/diethylphthalate 1:1
- Control group: test substance and test substance in ethanol/diethylphthalate 1:1
- Site: right flank (100% test substance) and a separate skin site on the right flank (50% test substance)
- Concentrations: 50% and 100%
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole, topical induction and challenge: 50% in acetone/Peg 400 (70:30)
Results and discussion
- Positive control results:
- A reliability test with 2-mercaptobenzothiazole (50% in acetone/Peg 400 (70:30)) was performed not more than 6 months previously (Feb 1999) using the same animal supplier. The incidence of sensitisation was 55% (11 out of 20 animals).
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; Challenge: 50% and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 100%; challenge: 50% and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 50% and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 100%; challenge: 50% and 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- other: not specified
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50% in induction and challenge
- No. with + reactions:
- 11
- Total no. in group:
- 20
Any other information on results incl. tables
Bodyweight gains of animals in the test group, between Day 0 and Day 30, were comparable to those observed in the control group animals over the same period.
No skin reactions were noted at the topical induction sites of test or control group animals at the 1, 8 or 15-day observations.
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-hour observations.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the Buehler test the test substance revealed no sensitising properties.
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