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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
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 7 days of observation
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
EC Number:
255-392-8
EC Name:
Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
Cas Number:
41484-35-9
Molecular formula:
C38H58O6S
IUPAC Name:
2-[(2-{[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]oxy}ethyl)sulfanyl]ethyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually
- Diet: ad libitum standard rabbit food - NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
3 animals (males): single application without washing
3 animals (females): single application, washing after 30 seconds
Observation period (in vivo):
7 days
Reading time points: day 1, 2, 3, 4, and 7
Number of animals or in vitro replicates:
3 males and 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3/6 animals the treated eye was rinsed 10 mL of lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: eyes not washed out
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: eyes not washed out
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Remarks on result:
other: eyes not washed out
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: eyes not washed out
Irritant / corrosive response data:
For the animals with eyes rinsed 30 seconds after treatment the same results were observed (scores for: cornea = 0, iris = 0, conjunctivae = 0, and chemosis = 0).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
Based on the results of this study, the test article is considered to be not irritating to the rabbit eye.
Executive summary:

An eye irritation similar to OECD 405 was performed with six female and male rabbits from russian breed. The eyes of three rabbits were left unwashed after application of 0.1 g unchanged test substance and the animals were observed 7 days. The mean scores for the 24, 48 and 72 h reading for conjunctivae redness, iritis, cornea opacity and conjunctivae chemosis were 0 at any reading time point. In three additional rabbits the eyes were rinsed 30 seconds after application of test substance. In this case the same results were observed. This indicates that the substance is not an irritant to the rabbit eye.