Phenol, 3-bromo-5-chloro-

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Version / remarks:

2004

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2002

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:

3-bromo-5-chlorophenol

EC Number:

611-435-6

Cas Number:

56962-04-0

Molecular formula:

C6H4BrClO

IUPAC Name:

3-bromo-5-chlorophenol

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Mice (non-pregnant, nulliparous, healthy Charles River Laboratories, Research Models and Services, Germany GmbH, Sanhofer Weg 7, 97633 Sulzfeld, Germany
Body weight (on testday 1) 19-25 g
Age (on testday 1) Approximately 5 weeks

Study design: in vivo (non-LLNA)

Positive control substance(s):

yes

Remarks:

alpha-hexyl cinnamic

Study design: in vivo (LLNA)

Vehicle:

other: acetone / olive oil (3:1 v/v)

Concentration:

5 %, 10 % and 25 %

No. of animals per dose:

6 animals per dose.

Details on study design:

Observed end points: cell count with a automatically cell counter (to measure primary proliferation of lymphocytes. No radioactive labelling have been used.), lymph node weight, ear weight, difference of ear thickness.

Positive control substance(s):

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

Statistics:

Stimulation index was calculated by divding the average absolute node weight or cell count per group of the test item treatred lymph nodes by the vehicles ones. For lymph node weight a significane at p

Results and discussion

Positive control results:

The positive control group caused the expected increases in cell count and ear weights (statistically significant at p <= 0.01).

In vivo (LLNA)

Results

Parameter:

SI

Remarks on result:

other: Stimulation indices of cell count: negative control (vehicle): SI = 1.000 5 % test item: SI = 1.110 10 % test item: SI = 1.318 25 % test item: SI = 1.347 positive control: SI = 2.059

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the present test conditions the test substance administered at concentrations of 5, 10 and 25 % (w/w) in acetone/olive oil (3:1 v/v) did not reveal any sensitisng properties in the local lymph node assay in mice.

Executive summary:

All parameters measured were taken into consideration for the categorsation of the test item regarding its possible sensitising potential.Treatment with the test substance at concentrations of 5 %, 10 %, or 25 % (w/w) did not reaveal statistically significantly increased values (p<= 0.01) for the lymph node weights, ear weights and cell counts. The stimulation index of the cell count did not exceed the threshold level of 1.4. No dose-related increase in lymph node weight was observed. No changes in behaviour were observed in any of the treated animals.