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Diss Factsheets

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

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
Chemical structure
Reference substance name:
7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone
EC Number:
204-980-2
EC Name:
7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone
Cas Number:
130-20-1
Molecular formula:
C28H12Cl2N2O4
IUPAC Name:
15,30-dichloro-2,17-diazaheptacyclo[16.12.0.0³,¹⁶.0⁴,¹³.0⁶,¹¹.0¹⁹,²⁸.0²¹,²⁶]triaconta-1(30),3,6,8,10,13,15,18,21,23,25,28-dodecaene-5,12,20,27-tetrone
Test material form:
solid: particulate/powder
Details on test material:
Vat Blue 6

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:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
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:
GHS criteria not met
Conclusions:
The test item ha no irritating effects in rabbit eyes