Reaction product of 2,4-bis(2-methylbutan-2-yl)phenol and phosphorous pentoxide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 20, 1982 to August 10, 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Study conducted according to GLP and was equivalent or similar to OECD 405 guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

impurity 1

Reference substance name:

2,4-di-tert-pentylphenol

EC Number:

204-439-0

EC Name:

2,4-di-tert-pentylphenol

Cas Number:

120-95-6

Molecular formula:

C16H26O

IUPAC Name:

2,4-bis(1,1-dimethylpropyl)phenol

Specific details on test material used for the study:

The test material is a UVCB

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Rabbits were housed individually in cages sized in accordance with the 'Guide for the Care and Use of Laboratory Animals' of the Institute of Laboratory Resources. Waste material was removed daily. Cages and feeders were sanitized every two weeks. Food and water was provided ad libitum, checked daily and added or replaced as needed.

ENVIRONMENTAL CONDITIONS

Temperature: 20 ◦C ± 3 ◦C
Relative Humidity: 30-70%
Light cycle: 12 hours light, 12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.1 mL of neat test material

Duration of treatment / exposure:

Test substance was placed in the right eye of each animal by gently pulling the lower lid away from the eyeball to form a cup. The upper and lower lids were then held together for one seconf to prevent loss of material

Observation period (in vivo):

Up to 21 days post dosing

Number of animals or in vitro replicates:

six animals (3 males, 3 females)

Details on study design:

Twenty four hurs prior to the application of the test material, the eyes of the rabbits were examined using 2% sodium fluorescein stain. Animals showing preexisting corneal injury were eliminated from the study. The test susbtance was placed in the right eye of each animal by gently pulling the lower lid away from hte eyeball (conjunctival cul de sac) to form a cup. The upper and lower lids were then gently held together for one seconf to prevent loss of material. The contralateral eye remained untreated and served as a control. The eyes were examined at 1, 24, 48 and 72 hours and 7, 14 and 21 days after treatment. The grades of ocular reaction were recorded at each examination

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2.973

Reversibility:

not fully reversible within: 21 days

Remarks on result:

probability of severe irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

1.86

Reversibility:

not fully reversible within: 21 days

Remarks on result:

probability of severe irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.996

Reversibility:

not fully reversible within: 21 days

Remarks on result:

probability of severe irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

3.16

Max. score:

4

Reversibility:

not fully reversible within:

Remarks:

21 days

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the results of this study, the test material is considered to cause irreversible damage to the eye. Therefore, under the criteria set forth in the CLP guidance document, this substance should be classified as Eye Damage, H318.

Executive summary:

The test article was instilled in the right eye of six rabbits. Positive ocular responses were observed at 1, 24, 48 and 72 hours, and on Days 7, 14 and 21 after treatment. Blistering and ulceration of the cornea, pannus and keratoconus were observed during the study. Based upon the observations made in the Acute Eye Irritation Test in Rabbits, the test substance was determined to be corrosive to the eye under CLP classification criteria.