6-tert-butyl-2,4-xylenol

Eye irritation

Administrative data

Endpoint:

eye 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:

other: Study performed in accordance with OECD & EU test guidelines.

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 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

See "Principles of Method if other than guideline"

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

See "Principles of Method if other than guideline"

Principles of method if other than guideline:

A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guidelines and no further animals were treated.

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:

other: liquid

Details on test material:

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

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Not specified in the report.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Not specified

Duration of treatment / exposure:

Single treatment

Observation period (in vivo):

Two days

Number of animals or in vitro replicates:

One animal (sex not specified)

Details on study design:

A single instillation of the test material to the non-irrigated eye of one rabbit.

Results and discussion

In vivo

Results

Irritation parameter:

maximum mean total score (MMTS)

Basis:

mean

Time point:

other: 48 hour

Score:

39

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation.

Other effects:

Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guidelines and no further animals were treated.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It is considered reasonable to assume that the test material is irritant according to EEC labelling regulations.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" referenced as Method B5 in Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

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

 

A single instillation of the test material to the non-irrigated eye of one rabbit produced areas of diffuse corneal opacity, iridial inflammation and moderate conjunctival irritation. Other adverse ocular effects noted were a dulling of the normal lustre of the corneal surface and petechial haemorrhage of the nictitating membrane. Two days after treatment the animal showed signs of respiratory problems which were thought to be treatment-related. The animal was therefore killed for humane reasons in accordance with current U.K. Home Office guideline and no further animals were treated.

 

The test material produced a maximum total score of 39.0 and was considered to be at least a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system (based on one rabbit only).

It is considered reasonable to assume that the test material is irritant according to EEC labelling regulations. As such, the 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 Eye Irritant

H319: Causes serious eye irritation

R 36- Irritating to the eyes