2,6-di-tert-butyl-4-nonylphenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 1 May 1995 and 5 May 1995.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 February 1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2,6-di-tert-butyl-4-nonylphenol

EC Number:

224-320-7

EC Name:

2,6-di-tert-butyl-4-nonylphenol

Cas Number:

4306-88-1

Molecular formula:

C23H40O

IUPAC Name:

2,6-di-tert-butyl-4-nonylphenol

Test material form:

liquid

Details on test material:

Clear colourless liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 99/26.12.94

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature under nitrogen

FORM AS APPLIED IN THE TEST (if different from that of starting material): clear colourless liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: supplied by David Percival Ltd., Moston, Sandbach, Cheshire, UK,
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.88 to 3.42 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): Free access to food (STANRAB SQC Rabbit Diet, Special Diets Services ltd., Witham, Essex, UK) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking waterwas allowed throughout the study.
- Acclimation period: a minimum acclimatisation period of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 22 °C
- Humidity (%): 58 to 66%.
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test material was instilled into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after instillation, to prevent loss of the test material, and then released.

Duration of treatment / exposure:

single treatment

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.

Number of animals or in vitro replicates:

One rabbit was initially treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix I, (from Draize J.H. (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington D.C. p.48 to 49).

TOOL USED TO ASSESS SCORE: . Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

586 Male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

7 Male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

121 Female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

586 Male

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

7 Male

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Remarks:

121 Female

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

586 Male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

7 Male

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

121 Female

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

586 Male

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

7 Male

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 12

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

121 Female

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

Residual test material was noted around all treated eyes at the 1-hour observation. Dulling of the normal lustre of the corneal surface was noted in one treated eye at the 1-hour observation.
Iridial inflammation was noted in two treated eyes at the 1-hour observation.
Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1-hour observation with minimal conjunctival irritation in two treated eyes at the 24-hour observation.
No ocular effects were noted in one treated eye at the 24-hour observation and the remaining treated eyes at the 48-hour observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, ISONOX 232, produced a maximum group mean score of 13.3 and was classified as a MINIMAL IRRITANT (CLASS 3 ON A 1 TO 8 SCALE) to the rabbit eye according to Regulation No. 1272/2008 (CLP). The test material did not produce positive criteria in any rabbit according to the EU labelling regulations. No symbol and risk phrase are therefore required.

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 No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 February 1987) and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Regulation No. 1272/2008 (CLP).

A single instillation of the test material to the non-irrigated eye of three rabbits produced iridial inflammation and minimal to moderate conjunctival irritation.

Dulling of the normal lustre of the corneal surface was also noted. No ocular effects were noted in one treated eye at the 24-hour observation and the remaining treated eyes at the 48-hour observation.

The test material produced a maximum group mean score of 13.3 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to Regulation No. 1272/2008 (CLP).

No symbol and risk phrase are required.