Registration Dossier
Registration Dossier
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EC number: 255-392-8 | CAS number: 41484-35-9
Eye irritation
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:
- 1 975
- 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
- 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
Constituent 1
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.
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