Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test substance was not judged to be a skin-sensitiser under the conditions of this study.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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)
- Specific details on test material used for the study:
- date of expiration: September 5, 2012
Storage: Room temperature - 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 - 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)
- Positive control results:
- DPM/animal: 4880.2
SI:17.7 - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
