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Toxicological information

Skin sensitisation

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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:
2018

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

Constituent 1
Chemical structure
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

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