Registration Dossier
Registration Dossier
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EC number: 216-378-7 | CAS number: 1569-69-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Cyclohexanethiol
- EC Number:
- 216-378-7
- EC Name:
- Cyclohexanethiol
- Cas Number:
- 1569-69-3
- Molecular formula:
- C6H12S
- IUPAC Name:
- cyclohexanethiol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): cyclohexylmercaptan
- Physical state: clear colourless liquid
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: individually in polypropylene cages
- Diet: 2014 Teklad Global rodent diet ad libitum
- Water: Mains tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 01 February to 25 February 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50 or 100% v/v
- No. of animals per dose:
- 1 per concentration preliminary screening test
5 per concentration main test - Details on study design:
- RANGE FINDING TESTS:
Two mice, 1 per concentration, were treated by daily application of 25 µl of the undiluted test material or the test material at a concentration of 50% v/v in vehicle, to the dorsal surface of each ear for 3 consecutive days. Any signs of toxicity or excessive local irritation noted during this period were recorded.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Skin Sensitisation: Local Lymph Node Assay
- Criteria used to consider a positive response: at least 1 concentration results in a threefold or greater increase in 3HTdR incorporation into lymph node cells of test nodes compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of 5 mice treated by daily application of 25 µl of the appropriate concentration of test material to the dorsal surface of each ear for 3 consecutive days, administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of 5 mice received the vehicle alone in the same manner. - Statistics:
- Individual and group mean disintegrations per minute values were assessed for dose response relationships by analysis of homogeneity of variance followed by one way analysis of variance (ANOVA). In the event of a significant result from the ANOVA, pairwise comparisons were performed between control and treated groups. For homogenous datasets Dunnett's Multiple Comparison test was used and for non-homogenous datasets Dunnett's T3 Multiple Comparison Method was used.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 25% v/v - 13.61 50% v/v - 17.65 100% v/v - 18.27
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM Vehicle - 1939.49 25% v/v - 26399.75 50% v/v - 34232.22 100% v/v - 35440.16
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test in a reliable study conducted to GLP.
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