6,6'-di-tert-butyl-4,4'-thiodi-m-cresol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 28 - April 4, 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Although the study was quite old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

not under GLP conditions, study dates 1986

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Slz WX-R
- Analytical purity: 99.93%
- Lot/batch No.: 8623

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Japan Lab Animals Co., Ltd.
- Age at study initiation: not mentioned.
- Weight at study initiation: 2.05-2.47 kg
- Housing: individual metal mesh-bottomed suspenses cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 - 42 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27
- Humidity (%): 45 - 75
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:

1, 24, 48, 72, (96 hours, 1 week): with or without washing after 30 seconds for 1 minute

Observation period (in vivo):

1, 24, 48, 72, (96 hours, 1 week)

Number of animals or in vitro replicates:

3 with washing; 3 without washing

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, in one group
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Criteria of Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

non-washed group

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 1 week

Remarks on result:

other: Score: 10.0, 6.7, 6.7, 1.7, 0 resp. at t = 24, 48, 72, 96 h, 1 week

Results 2

Irritation parameter:

iris score

Remarks:

non-washed group

Basis:

mean

Time point:

other: 1 h

Score:

1.7

Max. score:

5

Reversibility:

fully reversible within: 96 hours

Remarks on result:

other: Score: 5.0, 1.7, 1.7, 0, 0 resp. at t= 24, 48, 72, 96 h, 1 week

Results 3

Irritation parameter:

conjunctivae score

Remarks:

non-washed group

Basis:

mean

Time point:

other: 1 h

Score:

6

Max. score:

6

Reversibility:

fully reversible within: 96 hours

Remarks on result:

other: Score: 12.7, 4.0, 0.7, 0, 0 resp. at t = 24, 48, 72, 96 h, 1 week

Results 4

Irritation parameter:

cornea opacity score

Remarks:

washed group

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

0

Remarks on result:

other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h

Results 5

Irritation parameter:

iris score

Remarks:

washed group

Basis:

mean

Time point:

other: 1 h

Score:

0

Max. score:

0

Remarks on result:

other: Score: 0, 0, 0 resp. at t = 24, 48, 72 h

Results 6

Irritation parameter:

conjunctivae score

Remarks:

washed group

Basis:

mean

Time point:

other: 1 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Score: 2.7, 0, 0 resp. at t = 24, 48, 72 h

Irritant / corrosive response data:

In the non-washed group (3 animals), all of the cases showed conjunctival redness with a strength level of 1 and conjunctival edema with a strength level of 2 at 1 hour after Slz WX-R application, while 1 case showed iris hyperemia with a strength level of 1. No change in the strength of the conjunctival hyperemia was observed at 24 hours after application, but in all of the cases, the strength of the conjunctival redness increased to a level of 2. Further, 2 cases newly developed iris hyperemia with a strength level of 1, and all of the cases showed corneal opacity with a strength level of 1 and a breadth of 1 to 4 as well as eye discharge with a strength level of 2 to 3. These local reactions gradually lessened, with only 1 case showing corneal opacity with a strength level of 1 and a breadth of 1 at 96 hours after application. After 1 week, all of the local reactions had disappeared. In the washed group (3 animals), all of the cases showed conjunctival redness and conjunctival edema with a strength level of 1 at 1 hour after Slz WX-R application. By 24 hours after application, the conjunctival redness had disappeared in 1 case, and the conjunctival edema also disappeared in 2 cases. However, 1 case newly developed eye discharge with a strength level of 1. All of these local reactions disappeared by 48 hours after application.
Based on the above-noted results, the mean total scores for the local reactions in each tissue were calculated. The maximum value up to 72 hours after application was 27.7 at 24 hours after application in the non-washed group and 4.0 at 1 hour after application in the washed group. These results indicated that Slz WX-R showed moderate irritation of rabbit eyes in the non-washed group, with only extremely mild irritation in the washed group, demonstrating the effects of washing.

Other effects:

none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A study in 3 rabbits revealed that Slz WX-R 6 was moderately irritanting when the eyes were not washed and extremely mild irritating when the eyes were washed after 30 seconds of exposure. The study was not performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions, but was well performed and documented and as such considered reliable with minor restrictions.