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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:
12 - 19 Mar 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: modified ETAD method
Version / remarks:
based on FDA method (1959)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Common name: Basic Yellow 21 chloride

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Housing: single cage (Type III)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 7 - 14 d
- Sex: female
- Number of animals: 6

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60% r.h.
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Observation period (in vivo):
7 d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize score

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1, 2, 5, 6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 3, 4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal: 2, 3, 4, 5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal: 1, 6
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 3, 4, 5, 6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal: 1, 5, 6
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of moderate irritation
Irritation parameter:
chemosis score
Basis:
animal: 2, 3, 4
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 7 d
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Irreversible and diffuse cornea opacity, eye damaging, strong corrosive effects

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance caused severe effects in rabbit eyes (diffuse and irreversible cornea opacity). All symptoms described were not reversible within 7 d. The substance is classified as Category 1.