Registration Dossier
Registration Dossier
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EC number: 700-425-8 | CAS number: 521284-22-0
Endpoint summary
Administrative data
Description of key information
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
- 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
Reference
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
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