Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, no separate chemosis scores given.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

EC Number:

229-722-6

EC Name:

Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Cas Number:

6683-19-8

Molecular formula:

C73H108O12

IUPAC Name:

3-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}-2,2-bis({[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}methyl)propyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Specific details on test material used for the study:

- Storage condition of test material: 25 °C in a glass container sealed inside a polyethylene bag

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Keen Ridge Rabbit Ranch, Edgewood, New Mexico
- Weight at study initiation: 2.7 - 2.9 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: right eye

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg

Duration of treatment / exposure:

Single application

Observation period (in vivo):

72 h (1h, 4h, 24h, 48h and 72 h)

Number of animals or in vitro replicates:

6 (2 per wash condition)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 4 animals out of 6
- Time after start of exposure: 30 s and 5 min

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1h, 4h, 24h,48h and 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1h, 4h, 24h,48h and 72h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1h and 4h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 24h

Remarks on result:

other: Values for animals with the unwashed eyes. Animals with washed eyes had lower scores.

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Irritation was observed only in conjunctival tissue. Conjunctival responses were observed at all treatment levels at 1 h and generally consisted of mild redness. All treatment groups were judged normal at 48 h. The eye irritation caused by the test article was mild and transitory.

Any other information on results incl. tables

Table 1. Eye irritation response in rabbits treated with test material^a

Tissue graded	Average Irritation^b
	hours		days
	1	4	1	2	3
Wash at 30 s
Cornea	0	0	0	0	0
Iris	0	0	0	0	0
Conjunctive	1	2	0	0	0
Wash at 5 m
Cornea	0	0	0	0	0
Iris	0	0	0	0	0
Conjunctive	1	1	1	0	0
No wash
Cornea	0	0	0	0	0
Iris	0	0	0	0	0
Conjunctive	3	3	0	0	0

a) Two rabbits per wash condition.

b) Maximum cornea response = 80; maximum iris response = 10; maximum conjunctivae response = 20.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Irritation was observed only in conjunctival tissue during the first day after application.