Reaction mass of 4-tert-butyl-2,5-xylenol and 6-tert-butyl-2,4-xylenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 26 January 2010 and 16 February 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Meets the requirements of GLP. There are no deviations from the recommended guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol

EC Number:

911-254-5

Molecular formula:

Not applicable - Multiconstituent substance

IUPAC Name:

Reaction mass of 2-tert-butyl-4,6-dimethylphenol and 4-tert-butyl-2,5-dimethylphenol

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste -F40260 Linxe)
- Age at study initiation: 11 or 12 weeks old
- Weight at study initiation: between 2.42 kg and 2.62 kg
- Housing: individual box installed in conventional air conditioned animal husbanding
- Diet (e.g. ad libitum): foodstuff (SDS - CI5) was supplied freely.
- Water (e.g. ad libitum): Drinking water (tap-water from public distribution system) was supplied freely.
- Acclimation period: minimum 5-day acclimatization period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours after removal of the patch.
If no reaction is observed 72 hours after the treatment, the study is terminated. In case of persistent reactions, additional observations can be carried out from D4 to D14 in order to determine the reversible character of the lesions observed.

Number of animals:

3 male

Details on study design:

TEST SITE
- Area of exposure: about 6 cm2 per patch
- Type of wrap if used: the patch was secured in position with a strip of surgical adhesive tape under semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after the removal of the patch, the treated area was rinsed with distilled water.


SCORING SYSTEM: Erythema and Eschar formation (0 to 4) and Oedema (0 to 4)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(and eschar)

Basis:

animal #1

Remarks:

animal A9980

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 2

Irritation parameter:

erythema score

Remarks:

(and eschar)

Basis:

animal #2

Remarks:

animal A9981

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Remarks:

(and eschar)

Basis:

animal #3

Remarks:

animal A9982

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

animal A9980

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 5 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

animal A9981

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

animal A9982

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 4 days

Any other information on results incl. tables

A well defined to moderate erythema, associated with a slight to moderate oedema, was noted on the treated area of three animals, 1 hour after the patch removal. The oedematous and erythematous reactions were totally reversible between day 4 and day 5. On the cutaneous structure, slight dryness to roughness was noted from day 2 or day 3 and was totally reversible between day 9 and day 14.

Applicant's summary and conclusion

Interpretation of results:

other: skin irritant (Cat 2) (CLP Regulation EC no. 1272/2008)

Conclusions:

The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.

Executive summary:

The test item was applied, as supplied, at the dose of 0.5 mL, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 and the test method B.4 of the Council regulation No 440/2008. A well defined to moderate erythema, associated with a slight to moderate oedema, was noted on the treated area of three animals, 1 hour after the patch removal. The oedematous and erythematous reactions were totally reversible between day 4 and day 5. On the cutaneous structure, slight dryness to roughness was noted from day 2 or day 3 and was totally reversible between day 9 and day 14. The results obtained, under these experimental conditions, enable to conclude that the test item is irritant to skin.