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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
Study period:
August 3, 1981 - August 10, 1981
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:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
bis(2-ethylhexyl)[(4-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine; bis(2-ethylhexyl)[(4-methyl-2H-1,2,3-benzotriazol-2-yl)methyl]amine; bis(2-ethylhexyl)[(5-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine; bis(2-ethylhexyl)[(5-methyl-2H-1,2,3-benzotriazol-2-yl)methyl]amine; bis(2-ethylhexyl)[(6-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine
EC Number:
939-700-4
Molecular formula:
Unspecified
IUPAC Name:
bis(2-ethylhexyl)[(4-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine; bis(2-ethylhexyl)[(4-methyl-2H-1,2,3-benzotriazol-2-yl)methyl]amine; bis(2-ethylhexyl)[(5-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine; bis(2-ethylhexyl)[(5-methyl-2H-1,2,3-benzotriazol-2-yl)methyl]amine; bis(2-ethylhexyl)[(6-methyl-1H-1,2,3-benzotriazol-1-yl)methyl]amine
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: PP 126/1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
- Housing:individually in metal cages, numbered by ear tags
- Diet: NAFAG, No. 814, Gossau SG, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as a control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
one single application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
Evaluation of the eye reactions according to the Draize Scoring System.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Eyes of 3/6 animals were rinsed after approx. 30 seconds.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: 3/6 rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: 3/6 rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: rinsed
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: rinsed

Any other information on results incl. tables

Results: Eye irritation

 

Eye treatment

not rinsed

rinsed (after 30 s)

Animal no.

1

2

3

4

5

6

24 h

Cornea

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

1

1

2

1

1

1

Chemosis

0

1

1

1

1

1

Discharge

0

0

0

0

0

0

48 h

Cornea

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

1

0

1

1

0

0

Chemosis

0

0

1

1

1

0

Discharge

0

0

0

0

0

0

72 h

Cornea

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

0

1

1

1

0

0

Chemosis

0

0

1

1

1

0

Discharge

0

0

0

0

0

0

4 d

Cornea

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

0

1

1

1

1

0

Chemosis

0

0

1

1

1

0

Discharge

0

0

0

0

0

0

7d

Cornea

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

0

1

1

0

0

1

Chemosis

0

0

0

0

1

1

Discharge

0

0

0

0

0

0

Mean value 24, 48, 72 h

Cornea

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctiva

0.67

0.67

1.33

1.00

0.33

0.33

Chemosis

0

0.33

1.00

1.00

1.00

0.33

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this experiment the test material was found to cause a minimal irritation below the level of regulatory significance when applied to the rabbit eye mucosa.