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:

Not specified

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

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

Test material

Test material information

Constituent 1

Reference substance name:

6-tert-butyl-2,4-xylenol

EC Number:

217-533-1

EC Name:

6-tert-butyl-2,4-xylenol

Cas Number:

1879-09-0

Molecular formula:

C12H18O

IUPAC Name:

2-tert-butyl-4,6-dimethylphenol

Test material form:

not specified

Details on test material:

PHENOL,2-(1,1-DIMETHYLETHYL)-4,6-DIMETHYL

Specific details on test material used for the study:

No further details specified in the study report.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Not specified in the summary report.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

As per the guideline -0.5ml

Duration of treatment / exposure:

4 hour

Observation period:

72 hour

Number of animals:

Six animals (sex not specified).

Details on study design:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits.
An additional group of three rabbits was also treated.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

3.8

Reversibility:

not fully reversible within: 72 hours. Study terminated due to toxicity.

Remarks on result:

other: Study terminated due to toxicity.

Irritant / corrosive response data:

Surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted.
No corrosive effects were noted.

Other effects:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.
Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Based on these results the test material was classified as irritant according to EEC labelling regulations.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 404 "Acute Dermal Irritation/Corrosion" referenced as Method B4 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as abasicforclassificationand labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 91/325/EEC).

 

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits resulted in the death of one animal one day after treatment. It also became necessary to kill one animal for humane reasons later the same day owing to the development of severe respiratory problems. The surviving animal showed very slight to well-defined erythema and slight oedema at the treatment site during the study. The study was terminated after the 72-hour observation. At the time it was thought that the deaths may not have been treatment-related. An additional group of three rabbits was therefore treated. One rabbit in this group was also found dead two days after treatment. The two surviving animals showed very slight to well-defined erythema and very slight to moderate oedema at the treatment sites during the study. Incidents of crust formation were also noted. It was concluded that the deaths seen during this study were due to the toxicity of the test material. No further animals were treated.

 

Based on the results of the surviving animals the test material produced a primary irritation index of 3.8 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

The above results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). The following classification for irritant effects is therefore required:

 

Category 2 Skin Irritant

H315: Causes skin irritation 

R 38- Irritating to skin