Registration Dossier
Registration Dossier
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EC number: 915-610-0 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Oct - 22 Nov 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- no SDS pretreatment although undiluted test substance caused no skin reactions; no reliability check (positive control); no data on analytical purity of test substance given.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- yes
- Remarks:
- no SDS pretreatment although undiluted test substance caused no skin reactions; no reliability check (positive control); no data on analytical purity of test substance given.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH AND SOCIAL SECURITY OF THE GOVERNMENT OF THE UNITED KINGDOM, UK
- Type of study:
- guinea pig maximisation 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:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
- EC Number:
- 915-610-0
- Molecular formula:
- C13H2O
- IUPAC Name:
- Reaction mass of 1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol and 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)butan-2-one
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 430 - 533 g
- Housing: in groups of 10 in stainless steel cages
- Diet: antibiotic free guinea pig diet SQC, FD1 (Special Diets Services, Witham, England), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: preliminary study: 5 days; main study: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24 (On 3 occasions only, the recorded temperature was 1°C below the protocol specified range.)
- Humidity (%): 34 - 65 (On several occasions the recorded relative humidity fell below the range specified in the protocol, the reading of 34% being recorded on 2 occasions only. These deviations are considered not to have affected the outcome of the study.)
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 5% (v/v)
- Day(s)/duration:
- on Day 0; single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- on Day 7; 48 h
- Adequacy of induction:
- other: non-irritant test substance
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/diethylphthalate 1:1 (w/w) and unchanged (no vehicle)
- Concentration / amount:
- 100% and 50% (v/v)
- Day(s)/duration:
- on Day 21; 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
For the intradermal induction 0.1 mL of the test substance at concentrations of 0.5, 1, 2, 3, 4 and 5% in arachis oil BP were injected intradermally into the flanks of one animal. The highest concentration (5%) induced mild to moderate skin irritation and was selected for the main study. For the epicutaneous induction 4 animals (intradermally pretreated with FCA) were treated with the undiluted test substance and concentrations of 12.5, 25 and 50% (v/v) in ethanol/diethylphthalate 1:1 (w/w). Applications were made to the clipped flanks under occlusive dressings for 24 hours. Undiluted test article was found to be non irritant when applied topically and was therefore selected for the topical induction phase of the main study. Undiluted test substance and the 50% (v/v) concentration of the test substance were selected for the challenge of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: 5% test substance in arachis oil
Injection 3: 5% (v/v) formulation of test substance in 1:1 preparation of FCA/water
Epicutaneous: test substance undiluted
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: arachis oil
Injection 3: 5% formulation of arachis oil in 1:1 preparation of FCA/water
Epicutaneous: ethanol/diethylphthalate 1:1 (w/w)
- Site: shoulder region (intradermal + epicutaneous)
- Frequency of applications: once
- Duration: Days 0 - 7
- Concentrations: intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 21
- Exposure period: 24 h
- Test groups: test substance and vehicle
- Control group: test substance and vehicle
- Site: left flank (undiluted test substance) and right flank (50% test substance)
- Concentrations: 50% (v/v) and 100%
- Evaluation: 24 and 48 h after challenge patch removal
- Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge: 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Challenge: 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Following the challenge application of undiluted test substance and 50% (v/v) test substance in ethanol/diethylphthalate 1:1 (w/w), responses for all control and all test animals at the 24 and 48 hour observations were 0. The overall sensitisation rate was 0%.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification according to regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of the guinea pig maximisation test the test substance revealed no sensitising properties.
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