Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 15, 2010 - January 25, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- date of expiration: September 5, 2012
Storage: Room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:JN
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Females nulliparous and non-pregnant
- Age at study initiation: 7 weeks old
- Weight at study initiation: 18.9 to 21.9 g.
- Housing: wire mesh cages
- Diet: commercial pellet diet ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23±3°C
- Humidity (%): 55±20%RH
- Air changes (per hr): 12 times room volume or more
- Photoperiod (hrs dark / hrs light): 12 hours
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group 1: AOO
Group 2: 2% test substance
Group 3: 10% test susbtance
Goup 4: 50% test substance
Group 5: 25% HCA - No. of animals per dose:
- 4
- Details on study design:
- Group 1: AOO
Group 2: 2% test substance
Group 3: 10% test susbtance
Goup 4: 50% test substance
Group 5: 25% HCA - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- DPM/animal: 4880.2
SI:17.7
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 2% test substance
- Key result
- Parameter:
- SI
- Value:
- 2.6
- Test group / Remarks:
- 10 % test substance
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 50% test substance
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not judged to be a skin-sensitiser under the conditions of this study.
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