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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:
1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)
EC Number:
264-355-5
EC Name:
3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)
Cas Number:
63589-47-9
Molecular formula:
C20H26N3O.1/2Cl4Zn
IUPAC Name:
bis[3,7-bis(diethylamino)phenoxazin-5-ium] tetrachlorozincate(2-)
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: Hacking & Churchill Ltd. Huntingdon, UK
- Housing: single cage
- Weight: 3.5 - 3.8 kg
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): as lib.
- Acclimation period: 7 d

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
Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline

SCORING SYSTEM: Draize system

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:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Remarks on result:
probability of weak 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:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 d
Remarks on result:
probability of severe irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21
Remarks on result:
probability of severe irritation
Irritant / corrosive response data:
Conjunctivae redness and chemosis not fully reversible within 21 d in 2/3 animals.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on an OECD 405 study with rabbits, the substance causes severe damage to eyes. The substance is classifiable according to GHS Category 1 due to the lack of reversibility within 21 d (conjunctivae redness and chemosis).