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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:
February 8, 1982 - February 15, 1982
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:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, observation period 7 days)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine
EC Number:
939-703-0
Cas Number:
1474044-75-1
Molecular formula:
C16H19N - C28H43N (main constituents)
IUPAC Name:
Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine
Details on test material:
- Analytical purity: no data
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: UFA Versuchsbetrieb Buehl, CH-5604 Hendschiken
- Weight at study initiation: 2 - 3 kg
- Housing: individually in metal cages
- Diet: standard rabbit foot, NAFAG, No. 814, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: at least 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: the adjacent eye served as 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:
REMOVAL OF TEST SUBSTANCE
- Washing: in 3/6 animals
- Time after start of exposure: 30 s after application

SCORING SYSTEM: evaluation according to the Draize Scoring System at day 1, 2, 3, 4 and 7

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed, score = 2 in all 3 animals (24/48/72 h)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed; score = 3 in all 3 animals (24/48/72 h)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of 3 animals
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: not rinsed; score = 3 in all 3 animals (24/48/72 h)

Any other information on results incl. tables

Table 1: Results of eye irritation

 

Eye treatment

not rinsed

rinsed

Animal no.

1

2

3

4

5

6

24 h

Cornea

2

2

2

1

1

1

Area

4

4

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

2

3

2

Discharge

2

2

2

2

3

2

48 h

Cornea

2

3

2

1

1

1

Area

4

3

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

2

2

2

72 h

Cornea

2

3

2

1

2

2

Area

4

3

4

4

4

4

Iris

2

2

2

1

1

1

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

1

2

2

4 d

Cornea

2

3

2

1

3

3

Area

4

4

4

4

4

4

Iris

2

2

2

1

2

2

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

3

Discharge

2

2

2

0

1

2

7d

Cornea

2

4

3

2

3

4

Area

4

4

4

4

4

4

Iris

2

2

2

2

2

2

Conjunctiva

3

3

3

2

3

3

Chemosis

3

3

3

1

2

2

Discharge

2

2

2

0

1

1

Mean value 24, 48, 72 h

Cornea

2.00

2.67

2.00

1.00

1.33

1.33

Iris

2.00

2.00

2.00

1.00

1.00

1.00

Conjunctiva

3.00

3.00

3.00

2.00

3.00

3.00

Chemosis

3.00

3.00

3.00

1.33

2.33

2.00

Only the data of the animals that were not rinsed were considered for classification as, according to OECD guideline 405, the eyes should not be washed within 24 h after application. In this study, the eyes were washed 30 s after application.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this experiment the test material was found to cause a marked irritation when applied to the rabbit eye mucosa.