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Diss Factsheets

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
2 animals instead of 3
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(5-chlorobenzoxazol-2-yl)-7-(diethylamino)-2-benzopyrone
EC Number:
252-722-2
EC Name:
3-(5-chlorobenzoxazol-2-yl)-7-(diethylamino)-2-benzopyrone
Cas Number:
35773-43-4
Molecular formula:
C20H17ClN2O3
IUPAC Name:
3-(5-chloro-1,3-benzoxazol-2-yl)-7-(diethylamino)-2H-chromen-2-one
Test material form:
solid: particulate/powder
Details on test material:
Disperse Yellow 184:1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, UK
- Housing: polyethylene cages
- Diet: standard diet "Ssniff K 4" (Ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal and day; feeding once per day in the morning.
- Water: tap water was available for ad libitum consumption (between 7 and 19 hrs. from automatic watering apparatus)
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
50 mg / animal
Duration of treatment / exposure:
one treatment at 0 h
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

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
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:
0.17
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:
No signs of corrosion observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item caused no signs of irritation in rabbit eyes (cornea opacity, iris, conjunctivae redness, chemosis). The classification criteria of the CLP Regulation were not met. Therefore, the substance is not classifiable.