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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

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
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
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