4-bromo-α,α,α-trifluoro-m-toluidine

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:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

4-bromo-α,α,α-trifluoro-m-toluidine

EC Number:

206-885-1

EC Name:

4-bromo-α,α,α-trifluoro-m-toluidine

Cas Number:

393-36-2

Molecular formula:

C7H5BrF3N

IUPAC Name:

4-bromo-α,α,α-trifluoro-m-toluidine

Test material form:

solid: crystalline

Specific details on test material used for the study:

Manufacturer: Fuxin Jintelai FluorineBatch No.: 0026DB4 (D150701CC14001)Physical state: solid, crystalline substanceStorage in a cool, dry place

In vivo test system

Test animals

Species:

mouse

Strain:

CBA/Ca

Sex:

female

Details on test animals and environmental conditions:

Species and strain: CBA/Ca Ola Hsd miceSource: TOXI-COOP ZRT.Hygienic level during the study: Good conventionalSex: Female, nulliparous, non-pregnantAge of animals: Young adult mice; 10-12 weeks old (at start of the main test)Body weight range at starting: 18.9-23.7 gAcclimatization time: 7 daysAnimal health: Only healthy animals were usedHousing during acclimatization period: Grouped caging in small groupsHousing during the test: Grouped caging (4 animals/cage)Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 – 70 %

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Concentration:

Based on the preliminary test results 4-BROMO-3-(TRIFLUOROMETHYL)ANILINE (CAS No. 393-36-2) was tested in the LLNA at concentration of 100 % (i. e 1 g/mL) and at 50 %, 25 % and 10% (w/v) concentrations as formulations in N,N-Dimethylformamide (DMF).

No. of animals per dose:

Number of animals: 28 animals/main test (4 animals/treatment group)

Details on study design:

Animals in the treatment groups were treated with the relevant vehicles (DMF or AOO), appropriate formulations of the test item or 25 % concentration of the positive control substance. The test item was administered at four different concentrations according to the results of the dose range finding test.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Results

Parameter:

EC3

Value:

45

Applicant's summary and conclusion

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

Under the conditions of the present Local Lymph Node Assay, 4-BROMO-3-(TRIFLUOROMETHYL)ANILINE (CAS No. 393-36-2) tested at the maximum attainable concentration (based on solubility) of 100 % (i. e. 1 g/mL) and at concentrations of 50 %, 25 % and 10 % (w/v) as formulations in an appropriate vehicle (DMF) was shown to have skin sensitization potential. Based on the EC3 value calculated using dose-response curve analysis the test item was considered a weak skin sensitizer according to published data.