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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August 08, 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Similar Substance 01 - AY059
IUPAC Name:
Similar Substance 01 - AY059

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2.3 kg
- Housing: kept separately in metal cages (overall dimensions 47x32x34cm)
- Diet: standard diet of Nafag ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
1 minute
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 male and 3 female)
Details on study design:
Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with
physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
cornea opacity score
Remarks:
Opacity
Basis:
animal: 490, 497
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: washed eyes
Irritation parameter:
iris score
Basis:
animal: 490, 497
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 488
Time point:
other: mean value following grading at 24, 48 and 72 hours
Score:
ca. 2
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 490
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 497
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 488, 497
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 490
Time point:
other: mean value following grading at 24, 48 and 72
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: washed eyes

Applicant's summary and conclusion

Interpretation of results:
other: Irritating
Remarks:
According to the CLP Regulation Criteria used for interpretation of results: EU
Conclusions:
Irritant
Executive summary:

Method:

The eye irritation was determined in an irritation test on rabbits according to the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959), the US Association of Food and Drug Officials (AFDO), similar to OECD guideline 405.

0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula . After application, the eyelids were held open for a few seconds. The right eye was left untreated and served as a control. The eyes of 3 animals were rinsed 1 minute after application with

physiologic saline. The reactions were appraised with a slit lamp after 1 and 6 hours; 1; 2; 3; 6 and 8 days.

 

Result:

Irritant