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EC number: 213-590-1 | CAS number: 991-84-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-02-02 to 1981-02-09
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no data on test material purity, eye irritation was not examined 1 hour after exposure, the solid test substance was removed from the rabbits' eye already after 30 seconds instead of 1 hour)
- 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:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- EC Number:
- 213-590-1
- EC Name:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- Cas Number:
- 991-84-4
- Molecular formula:
- C33H56N4OS2
- IUPAC Name:
- 2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol
- Details on test material:
- - Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bred and raised on the premises
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: Standard rabbit food, NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: For a minimum of 4 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 14/10
Only rabbits with normal ophtalmic findings were used for these tests.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The second eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 10 ml of physiological saline (only 3 animals)
- Time after start of exposure: Approximately 30 seconds
SCORING SYSTEM: According to Draize
TOOL USED TO ASSESS SCORE: Slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animals' eyes were rinsed after treatment
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animals' eyes were not rinsed after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animals' eyes were rinsed after treatment
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: animals' eyes were not rinsed after treatment
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: animals' eyes were rinsed after treatment
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: animals' eyes were not rinsed after treatment
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: animals' eyes were rinsed after treatment
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48, and 72 hours
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: animals' eyes were not rinsed after treatment
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance revealed no eye irritating properties under the test conditions.
- Executive summary:
In an acute eye irritation study similar to OECD guideline 405, 0.1 g of the test substance was administered to 3 male and 3 female New Zeeland White rabbits. The test substance was placed into the conjunctival sac of the left eye of each animal; the right eye remained untreated and served as 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 evaluated according to Draize on day 1, 2, 3, 4, and 7. The cornea and iris scores were grade 0 in the mean over 24, 48 and 72 hours in all 6 animals (both with and without washing). The conjunctiva score was 0.4 for the animals whose eyes were washed and 0.3 for the animals whose eyes were not washed, respectively. The redness was reversible within 72 hours. The chemosis score was grade 0.1 in the mean over 24, 48 and 72 hours in all 6 animals (both with and without washing) and the eye irritating effect was fully reversible within 48 hours. Concluding, the test substance revealed no eye irritating properties under the test conditions.
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