Molybdenum, bis(N,N-dibutylcarbamodithioato-κS,κS')dioxodi-μ-thioxodi-, stereoisomer

Endpoint summary

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:

guideline study

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)

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:

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)

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

Interpretation of results:

other: no skin sensitising potential

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No in vitro tests for testing of a skin sensitisation potential could be performed due to insolubility of the substance in test-compatible solvents. Therefore, an in vivo test (LLNA) was performed with the test substance. Based on the result it was concluded that the substance does not have a skin sensitising potential and therefore does not need to be classified according to Regulation 1272/2008.