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
Study period:
13 September 1982 - 20 October 1982
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: 16 CFR 1500.42 Federal Hazardous Substances Act
GLP compliance:
yes
Remarks:
GLP-like study (QA signature)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: No data available.
- Age at study initiation: No data available.
- Housing: Stainless steel with elevated wire mesh flooring; 1 rabbit per cage
- Diet: Wayne 15% Rabbit Ration ad libitum
- Water: Tap water ad libitum
- Acclimation period: acclimated to the laboratory for an appropriate time prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 ± 2°F (22°C)
- Humidity (%): 45 ± 5%
- Air changes: controlled environment, but no air change information provided.
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

IN-LIFE DATES: From: 1982-09- 13 To: 1982 -09-20

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Eyes were not rinsed throughout study
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
Six rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not applicable
- Time after start of exposure: Not appliacable

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 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not classified
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 not 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 irritation was observed in any animal at any observation period.

Conclusion

In accordance with EU CLP Regulation No. 1272/2008 classification of this substance is not required for eye irritation.