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EC number: 274-570-6 | CAS number: 70321-86-7
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- Endpoint summary
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Terrestrial toxicity
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
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: see 'Remark'
- Remarks:
- Comparable to guideline standards with acceptable restrictions - analytical purity of the test substance not indicated - reporting deficiencies: individual animal scores not provided (only average scores were provided). As a consequence, effects on unwashed eyes could be only partly evaluated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (14/10 hour dark/light rhythm, 6 test animals, result reporting deficiencies)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Register, 38, No.187 §1500.42
- Principles of method if other than guideline:
- Draize method
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- EC Number:
- 274-570-6
- EC Name:
- 2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol
- Cas Number:
- 70321-86-7
- Molecular formula:
- C30H29N3O
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-4,6-bis(2-phenylpropan-2-yl)phenol
- Test material form:
- solid
- Details on test material:
- - Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: no data
- Batch No.: A 16-234/5
- pH: 6
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Himalayan breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, 8741 Sulzfeld, Germany
- Weight at study initiation: 1.5 - 2 kg.
- Housing: individually in metal cages
- Diet: ad libitum; standard rabbit food (NAFAG Gossau SG)
- Water: ad libitum
- Acclimation period: at least 4 days. Only rabbits with normal opthalmic findings were used in the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye (not treated)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 g - Duration of treatment / exposure:
- After instillation, eyes were not washed
- Observation period (in vivo):
- Eye irritation was scored on day 1, 2, 3, 4, and 7
- Number of animals or in vitro replicates:
- 6
- animals 1 - 3 (eyes were not washed)
- animals 4 - 6 (eyes were washed) - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes (in 3 of 6 animals); with luke warm water (10 mL)
- Time after start of exposure: 30 sec. after instillation
SCORING SYSTEM: draize scoring system
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed eyes)
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed eye)
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed eye)
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (washed eye)
- Basis:
- mean
- Remarks:
- of animal # 4, 5 and 6
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Remarks:
- (washed and unwashed eye)
- Basis:
- mean
- Remarks:
- (of all 6 animals)
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed eye)
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed eye)
- Basis:
- animal #2
- Time point:
- other: mean over 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Due to reporting style, draize scores at 24 hours could not be deciphered. However, effect that occurred at 24 hours was reversible within 48 hours.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed eye)
- Basis:
- animal #3
- Remarks on result:
- other: Due to reporting style, draize scores could not be deciphered. However, effect that occurred was reversible within 7 days.
- Irritation parameter:
- conjunctivae score
- Remarks:
- (washed eye)
- Basis:
- mean
- Remarks:
- of animal # 4, 5 and 6
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed eye)
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed eye)
- Basis:
- animal #2
- Time point:
- other: mean over 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48
- Remarks on result:
- other: Due to reporting style, draize scores at 24 hours could not be deciphered. However, effect that occurred at 24 hours was reversible within 48 hours.
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed eye)
- Basis:
- animal #3
- Remarks on result:
- other: Due to reporting style, draize scores could not be deciphered. However, effect that occurred was reversible within 7 days.
- Irritation parameter:
- chemosis score
- Remarks:
- (washed eyes)
- Basis:
- mean
- Remarks:
- mean of animal # 4, 5 and 6
- Time point:
- other: mean over 24, 48 and 72 hours after treatment
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
As a consequence of the poor documentation of the results (only average scores but not individual animal scores were provided), the parameters conjunctivae redness and swelling could not be assessed fully for unwashed eyes. Nevertheless, from the documented results, it is evident that conjunctival effects were totally absent in one animal over the observation period (score = 0), fully reversible in the second animal within 48 hours after start of treatment and fully reversible in the third animal by day 7.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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