Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 November - 29 December, 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is performed according OECD Guideline 406 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was conducted prior to the introduction of the LLNA method being available.

Test material

Test material information

Constituent 1

Reference substance name:

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

EC Number:

271-867-2

EC Name:

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene

Cas Number:

68610-51-5

Molecular formula:

C10H12.C7H8O.C4H8

IUPAC Name:

2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol

Details on test material:

-Name of test material (as cited in study report): Wingstay L
- Substance type: tan solid
- Physical state: solid
- Analytical purity: not stated in the report
- Impurities (identity and concentrations): not stated in the report
- Composition of test material, percentage of components: not stated in the report
- Purity test date: not stated in the report
- Lot/batch No.: 211093
- Expiration date of the lot/batch: May 2000
- Stability under test conditions: not stated in the report

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Elm Hill Breeding Laboratories
- Age: 5 weeks
- Weight at study initiation: 300 - 355 g
- Housing: individually in wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 C
- Humidity (%): 40 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

petrolatum

Concentration / amount:

5% (intradermal) and 25% (epicutaneous)

Challenge

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5%

No. of animals per dose:

10/sex for both vehicle control and test substance; 3/sex for positive control

Details on study design:

RANGE FINDING TESTS: 4 guinea pigs exposed to varying concentrations

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 test sites per animal
- Exposure period: 7 + 14 days
- Test groups: 5 (intradermal) and 25% Wingstay L (topical)
- Control group: Vehicle and DNCB
- Site: 6 sites
- Frequency of applications: once at day 0 and day 8
- Duration: 7 + 14 days
- Concentrations: 5 and 25% Wingstay L

B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: at day 22 and day 28
- Exposure period: 24 hours
- Test groups: 5% Wingstay L
- Control group: Vehicle and DNCB
- Site:
- Concentrations: 5% Wingstay L
- Evaluation (hr after challenge): 24 and 48 hours

OTHER:

Challenge controls:

1-chloro-2,4-dinitrobenzene (DNCB)

Positive control substance(s):

yes

Results and discussion

Positive control results:

See table 1 and 2.

In vivo (non-LLNA)

Results

Remarks on result:

other: See table below

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

A study in 46 male and female guinea pigs revealed that Wingstay L did induce a mild dermal sensitization response (Grade II) upon 5% intradermal and 25% topical exposure. However, this result is not considered sufficient to classify the substance according to CLP. The study was performed according to the general guidelines for hypersensivity testing under GLP conditions.