Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene were tested in guinea pigs according to OECD Guidelines 406, under GLP conditions. The substance elicited a mild dermal sensitization response (Grade II) when challenged and rechallenged at 5%.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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.
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
Route:
intradermal and epicutaneous
Vehicle:
petrolatum
Concentration / amount:
5% (intradermal) and 25% (epicutaneous)
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
Positive control results:
See table 1 and 2.
Remarks on result:
other: See table below

none

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The data of one study in guinea pigs meets the requirements of the current guidelines, although the identity and quality control of the tested substances is not demonstrated. Assuming that a 100% pure testing substance was used, a mild dermal sensitization response (Grade II) was elicited. This response, however, is not considered sufficient to classify the substance (see justification for non-classification).

Justification for selection of skin sensitisation endpoint:

Only 1 study is available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In view of GHS classification, in an adjuvant type test method a response in at least 30% of the animals is considered as positive. In the evaluated guinea pig study (with adjuvants): ca 15% of the animals responded at t = 48 hours after challenge and rechallenge. As this is below the GHS threshold of 30%, the substance should not be classified as a skin sensitizer.