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Diss Factsheets

Toxicological information

Eye irritation

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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12
Version / remarks:
February 1965
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Vat Blue 014 - Similar Substance 01
IUPAC Name:
Vat Blue 014 - Similar Substance 01
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ciba-Geigy
- Age at study initiation: 12 to 15 weeks
- Weight at study initiation (means): males: 2.58 Kg; females: 2.73 Kg
- Housing: single
- Diet ad libitum: Styles-Oxoid
- Water ad libitum: sterile filtered water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 to 70
- Photoperiod (hrs dark / hrs light): 14/10

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
3 rabbits: 30 sec
3 rabbits: 1 hour
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 males + 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 rabbits with warm water
- Time after start of exposure: in 3 rabbits after 30 seconds

SCORING SYSTEM: "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no symptoms observed
Irritation parameter:
iris score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no symptomes observed
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 14, 15
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no symptoms observed
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 16
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no symptomes observed
Irritant / corrosive response data:
Slight reddening, swelling and discharge was observed in all animals 1 hour after treatment. Two rabbits still showed minimal reddening 24 hours after treatment, which was no longer visible at 48 hours.

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not eye irritant
Executive summary:

The test item has no irritating effects in rabbit eyes.