Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982-05-03 to 1982-05-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-like study (QA signature), guideline study

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:
other: Section 1500.3- Federal Hazardous Substances Act Regulations - 16 CFR
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Fasting period before study: No
- Housing: stainless steel cage with elevated wire mesh flooring
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70±2°F
- Humidity (%): 45±5%
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-05-03 To: 1982-05-24

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Eyes were not rinsed throughout study
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0.72
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Not reversible in 5/6 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Not reversible in 4/6 animals

Any other information on results incl. tables

Table 1: Observations

Rabbit Number

Cornea

Iris

Conjunctivae

Chemosis

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

24 h

48 h

72 h

1

1

1

1

0

0

0

2

2

2

4

4

4

2

1

1

1

0

0

0

2

2

2

4

4

4

3

0

0

0

0

0

0

2

2

2

4

4

4

4

1

1

1

0

0

0

2

2

2

4

4

4

5

0

0

1

0

0

0

2

2

2

4

4

4

6

1

1

1

0

0

0

2

2

2

4

4

4

Mean Total

0.72

0

2.0

4.0

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is required for eye irritation.
Executive summary:

Test Guidance

Eye irritation study performed by a similar method to 16 CFR 1500.42 of the Federal Hazardous Substances Act,

Method and Material

0.1 mL of the test material was instilled into the right eye of six young adult albino rabbits. The left eye served as the untreated control. The test material was not washed from the eye. Treated eyes were examined at 1, 2, 3, 4 and 7 days following treatment. Interpretation of results was made in accordance with the Draize scale.

Results

No effects on the iris were observed in any animal at any observation period. Redness of the conjunctivae had dissipated in all animals by the 14 day observation period. Mild irreversible (5/6 animals) opacity of the cornea was observed throughout the study period. Severe chemosis was observed in all animals up to 7 days after test material installation. Chemosis in 3 animals appeared to have reversed by the 14 day observation but mild chemosis was seen at 21 days in these animals. One further animal showed no indication of reversibility of chemosis throughout the study period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance as Cat 1: Irreversible effects on the eye, is required for eye irritation.