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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
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.

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

Constituent 1
Chemical structure
Reference substance name:
α-tocopherol
EC Number:
200-412-2
EC Name:
α-tocopherol
Cas Number:
59-02-9
Molecular formula:
C29H50O2
IUPAC Name:
2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)chroman-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

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
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.