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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate
EC Number:
201-899-4
EC Name:
Ethyl 5-oxo-1-phenyl-2-pyrazoline-3-carboxylate
Cas Number:
89-33-8
Molecular formula:
C12H12N2O3
IUPAC Name:
ethyl 5-oxo-1-phenyl-4,5-dihydro-1H-pyrazole-3-carboxylate
Details on test material:
purity: 99.7%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.9 - 3.9 kg
- Housing: in single cages located in completely air conditioned rooms
- Diet: Altromin 2123 Haltungsdiat - Kaninchen, Altromin-GmbH, Lage/Lippe, ad libitum plus 15 g hay per day
- Water: deionized and chlorinated water from automatic dispensors ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50 +- 20
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye
Amount / concentration applied:
100 mg in the conjunctivae of the left eye
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: withphysiologic saline solution (37°C)
- Time after start of exposure: 24 hours

SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae: 0 - 3; chemosis: 0 - 4

TOOL USED TO ASSESS SCORE: UV hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the test results the substance has not to be classified for eye irritation.
Executive summary:

The susbstance was tested for eye irritarion according to OECD guideline 405. 3 New Zealand albino rabbits were administered 100 mg of the substance in the conjunctivae sack of the left eye. The untreated right eye was the control. 1 hour after removal the animals showed slight conjunctivae swelling and chemosis. But these symptoms were completely reversible after 24 hours.