Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 288-293-3 | CAS number: 85711-34-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ENVIGO, San Pietro al Natisone, Italy
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF at arrival, standard hausing during the study
- Age at study initiation: 12 weeks
- Weight at study initiation: 20.1-21.9 g
- Housing: group housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum) : ad libitum
- Acclimation period: 35 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-25.7
- Humidity (%):27-80
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 5, 2.5, 1, and 0.5%
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: methylethylketone proved to be a suitable solvent
- Irritation: yes (at concentrations >= 5%)
- Systemic toxicity: yes (at concentrations >= 5%)
- Ear thickness measurements: yes
- Erythema scores: yes
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- the stimulation index of 8.8 at 25% hexyl cinnamic aldehyde was in line with historical control data.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 4.8
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 4.4
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 1%
- Parameter:
- SI
- Value:
- 3.9
- Test group / Remarks:
- 0.5%
- Cellular proliferation data / Observations:
- see copies of tables on body weights, on DPM and calculated stimulation index attached in background material
Applicant's summary and conclusion
- Interpretation of results:
- other: skin sensitising potential
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.
