Tocopherols

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliable guideline study with limited information about the test item, please refer to IUCLID section 13 for read across justification.

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)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

α-tocopherol

EC Number:

200-412-2

EC Name:

α-tocopherol

Cas Number:

59-02-9

Molecular formula:

C29H50O2

IUPAC Name:

(2R)-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-3,4-dihydrochromen-6-ol

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): 82-0146, MX-6059

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: New York State Rabbit Development, Hartwick, N.Y.
- Weight at study initiation: 2 - 4 kg
- Housing: individually housed in wire mesh bottom cages in an environment-controlled room and quarantined for a minimum of 5 days
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

6 animals (no wash-out)
3 animals (wash-out 4s after instillation)

Observation period (in vivo):

24, 48, 72 h, 7 days

Number of animals or in vitro replicates:

6 animals (no wash-out)
3 animals (wash-out 4s after instillation)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): done in 3 animals
- Time after start of exposure: 4s after instillation

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: eyes were examined with sodium fluorescein and an ultraviolet lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24,48,72 h

Score:

0

Max. score:

3

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

None of the animals showed signs of irritation after instillation of the test item in the eye.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information

Conclusions:

The test article is considered to be non-irritating to the rabbit eyes without a washout and with a washout 4 seconds after instillation.

Executive summary:

The eyes of six animals were not washed out after instillation of the test article. The eyes of 3 animals were washed out, approximately 4 seconds after instillation of the test article, by flushing with physiological saline until all visible test article was removed.

Single application of the test item in the eyes of 9 rabbits was well-tolerated (primary irritation score = 0.0).

Based on this result it can be expected that the test item is not irritating to eyes.