m-terphenyl-2'-ol

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:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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)

Remarks:

testing lab.

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

m-terphenyl-2'-ol

EC Number:

219-401-9

EC Name:

m-terphenyl-2'-ol

Cas Number:

2432-11-3

Molecular formula:

C18H14O

IUPAC Name:

3-phenyl-[1,1'-biphenyl]-2-ol

Details on test material:

- Name of the test substance used in the study report: 2,6-Diphenylphenol
- Test substance No.: 10/0493-1
- Batch No.: LV 83/2010
- Purity: 99.5%
- Homogeneity: homogeneous by visual inspection
- Storage stability: The stability under storage conditions over the study period was guaranteed by the sponsor.

In vivo test system

Test animals

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 8 – 12 weeks
- Weight at study initiation: 18.7 g – 22.2 g
- Housing: individual housing in Makrolon cages, type II
- Diet (e.g. ad libitum): Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (LLNA)

Vehicle:

dimethylformamide

Remarks:

DMF was used as the vehicle because good solubility of the preparation was achieved.

Concentration:

25 μL per ear

No. of animals per dose:

5

Positive control substance(s):

other: Alpha-Hexylcinnamaldehyde, techn. 85%

Results and discussion

Any other information on results incl. tables

No signs of systemic toxicity were noticed in all animals during the study period. The expected mean body weight gain was generally observed in the course of the study.

When applied as 50% solution in DMF, the test substance did not induce a biologically relevant increase (no increase above the cut off Stimulation Index of 3) of 3H-thymidine incorporation into the cells from the auricular lymph nodes. However, a statistically significant increase for 3H-thymidine incorporation was noted. There were no statistically significant or biologically relevant increases in lymph node cell counts, lymph node weights or ear weights as well. The test-substance preparation did not cause any increase in ear weights, demonstrating the absence of relevant ear skin irritation.