Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7/12/82 to 9/16/82
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP conducted according to guideline 16 CFR Section 1500.42 of the Federal Hazardous Substances Act Regulations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR- Federal Hazardous Substances Act Regulations- Section 1500.42
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3Temperatuire - 70°F (± 2°F)Relative Humidity 45% (± 5%)Light: 12 hour light/dark cycleDiet - Wayne 15 % Rabbit Ration and tap water were provided ad libitum.Caging: Stainless steel with elevated wire mesh flooring. 1 rabbit/cageBedding: Deotized Animal Cage Board (DACB). Sheperd Products Company. Kalamazoo, Michigan 49005

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Test material instilled in the right eye while the left eye served as control
Amount / concentration applied:
0.1 ml of the experimental material
Duration of treatment / exposure:
Material was not washed from the eyes
Observation period (in vivo):
The treated eyes were examined at one, two, three, four and seven days following instillation of the test material into the eyes
Number of animals or in vitro replicates:
Six healthy young adult new zealand White rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): NoSCORING 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
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hour
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritant effects were noted at any timepoint in the study.

Any other information on results incl. tables

All the individual daily scores for all the rabbits are 0. That means:

No Opacity of Cornea for all the animals, for all records.

Normal irises for all the animals, for all records.

Neither chemosis nor redness of the conjuntivaes for all the animals, for all records.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no irritant effects in the eye of rabbits.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 effects were 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.