Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo study are available
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 25 1981 to August 6, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published for Food and Drug Officials of the United States, pag. 49-52, 1959.
Deviations:
no
GLP compliance:
no

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
- Weight at study initiation: 2- 3 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
directly injected into the conjunctival sac
Observation period (in vivo):
1, 2, 3, and 7 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, after 24 hours with a sodium chloride solution

SCORING SYSTEM: Draize test

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope and fluorescein after 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 3, 4, 6
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No ocular effects observed
Remarks on result:
other: rinsed eye
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: 1, 2, 4, 6
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0
Max. score:
2
Reversibility:
other: No ocular effects observed
Remarks on result:
other: rinsed eye
Irritation parameter:
iris score
Basis:
animal: 3, 5
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 1, 4, 5
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal: 1, 2, 4, 6
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: No dermal effects observed
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: rinsed eye
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: mean score after 24, 48 and 72 hours
Score:
ca. 1.66
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: rinsed eye
Irritant / corrosive response data:
All signs are reversible within 7 days after the application

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP principles (EC n. 1272/2008)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritant
Executive summary:

The substance was tested for eye irritation according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" published for Food and Drug Officials of the United States, pag. 49-52, 1959. All signs are reversible within 7 days of observation period.

Under the test conditions the substance is considered to be not irritant.