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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
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:
1978
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

Constituent 1
Chemical structure
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

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