Registration Dossier
Registration Dossier
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: 204-612-0 | CAS number: 123-25-1
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Non sensitising
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:
- April - May 2004
- 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)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: EPFS 201
- Expiration date of the lot/batch: 2005-06-30 - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: ca 8 weeks
- Weight at study initiation: 18 - 22 g
- Housing: Individually caged
- Diet (e.g. ad libitum): Commercial rodent diet (Altromin), ad libitum
- Water (e.g. ad libitum): Municipal supply, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 22 deg C
- Humidity (%): average 46.7%
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 2004-04-27 To: 2004-05-04 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: within normal range
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: allocated by random assigment
- Criteria used to consider a positive response: 3 fold or greater increase in stimulation index
TREATMENT PREPARATION AND ADMINISTRATION:
- as per OECD methodology - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- 25% HCA resulted in a SI of 5.8
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Low dose (25%)
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- Mid dose (50%)
- Parameter:
- SI
- Value:
- 0.5
- Test group / Remarks:
- High dose (100%)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The local lymph node assay (LLNA) indicates that the substance is not a skin sensitiser.
- Executive summary:
Potential dermal sensitisation has been investigated in-vivo using the local lymph node assay (LLNA). There was no indication from the resultant stimulation indices that the substance acts as a sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Based on the results of the available data the substance does not require to be classified and labelled according to Regulation 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).
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.
