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Description of key information

Skin sensitisation: Non sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.

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).