Registration Dossier
Registration Dossier
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EC number: 825-571-0 | CAS number: 60428-79-7
Skin sensitisation
Administrative data
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- EC Number:
- 825-571-0
- Cas Number:
- 60428-79-7
- Molecular formula:
- C18H36Mo2N2O2S6
- IUPAC Name:
- Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 18.7 - 23.3 g
- Housing: in groups up to five animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48 - 69
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: To:
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25, 50%
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: substance is a powder and was formulated with acetone/olive oil (4:1 v/v)
- Irritation: no
- Systemic toxicity: no
- Ear thickness measurements: yes
- Erythema scores: no
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA (OECD 429)
- Criteria used to consider a positive response: stimulation index (SI) was calculated based on DPM values; SI >= 3 indicates a sensitising potential
TREATMENT PREPARATION AND ADMINISTRATION:
the test substance was applied on three consecutive days on the dorsal surface of both ears (25 µl/ear) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10% concentration
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25% concentration
- Key result
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 50% concentration
Applicant's summary and conclusion
- Interpretation of results:
- other: no skin sensitising potential
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