Registration Dossier
Registration Dossier
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EC number: 228-985-4 | CAS number: 6386-38-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 8, 1982 - March 15, 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP study, according to EPA guidelines, with sufficient details
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Proposed Guidelines of the United States Environmental Protection Agency (EPA) § 163.81-4 "Primary eye irritation study". Federal Register, Vol. 43, No. 163, August 22, 1978.
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- EC Number:
- 228-985-4
- EC Name:
- Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
- Cas Number:
- 6386-38-5
- Molecular formula:
- C18H28O3
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madorin
- Weight at study initiation: 2 to 3 kg
- Housing: individually in metal cages
- Diet: ad libitum, NAFAG, No. 814, Gossau SG
- Water: ad libitum
- Acclimation period: a minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- not specified
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 3 rabbits: eye lid held close for a few seconds, no further washing
3 rabbits: eye lid held close for a few seconds, then flushing with 10 ml of physiological saline - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 10 ml of physiological saline
- Time after start of exposure: 30 s
SCORING SYSTEM: Draize Score
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Primary Irritation Index
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4, 7 days
- Score:
- 0.7
- Max. score:
- 110
- Remarks on result:
- other: based on non rinsed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: based on non rinsed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: based on non rinsed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- within 48 hours
- Remarks on result:
- other: based on non rinsed eyes. minimal redness observed in one animal
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: based on non rinsed eyes
- Other effects:
- No effects were observed with the rinsed eyes.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this experiment the test material was found to be not irritating to the rabbit eye.
- Executive summary:
The test substance was applied to 3 male and 3 female New Zealand White rabbits. An amount of 0.1 ml of the test article was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline. The eye irritation was scored on day 1, 2, 3, 4 and 7. One animal (non rinsed) showed minimal redness of the conjunctivae, reversible within 48 hours. All other animals were free of effects at any point of time during the course of the study. Therefore, the test substance was considered to be not irritating.
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