Registration Dossier

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD-Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granules
Details on test material:
- Name of test material (as cited in study report): Benzotriazol
- Synonyms: Preventol CI8; Preventol CI8-100
- Substance type: pale yellow granules
- Physical state: solid
- Lot/batch No.: 909

Test animals / tissue source

Species:
rabbit
Strain:
other: HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Interfauna UK Ltd

- Weight at study initiation: 3.0 - 3.7 kg
- Housing: standard single animal cages
- Diet: ssniff K 4 ad libitum
- Water: ad libitum
- Acclimation period: two weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +- 2 °C
- Humidity (%): 45 - 65%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
100 µl/ 70 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological NaCl-Solution
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: optical devices and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0.66
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
1.66
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
2.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
7 d
Score:
0
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the Evaluation of the Draize scores, Benzotriazole is mildly irritating to the eyes of rabbits. (MTS (24h) = 18; MTS (96h) N/A; MTS (72 h) = 1