Registration Dossier

Administrative data

Description of key information

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP and OECD/EC methods
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymphnode assay (LLNA)
Test material information:
Composition 1
Species:
mouse
Strain:
CBA
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann, D-33178 Borchen
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 19-24g
- Housing: IVC cages, type II L, polysulphone cages and Altromin saw fibre bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 degrees C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
dimethyl sulphoxide
Concentration:
6.25, 12.5 and 25%
No. of animals per dose:
5
Details on study design:
RANGE FINDING TESTS:
- Compound solubility: max 25%
- Irritation: negative

MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: SI > 3
Positive control substance(s):
other: Phenylene diamine
Positive control results:
SI = 7.2 (mean 5 animals) with Phenylene diamine
Parameter:
SI
Remarks on result:
other: Concentration SI 6.25% 13.6 12.5% 13.3 25% 13.3
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Concentration DPM 6.25% 4303 12.5% 4193 25% 4195
Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is classified as a skin sensitiser under EU criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The test substance at three concentrations gave a dose-dependent SI response of > 3 indicating that the test substance may be a non-threshold skin sensitiser.


Migrated from Short description of key information:
Substance tested for skin sensitisation in mouse local lymph node assay

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Substance gave a dose-independent SI response of 13 and is therefore classified as a skin sensitiser