Registration Dossier
Registration Dossier
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EC number: 603-923-2 | CAS number: 135590-91-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
- EC Number:
- 603-923-2
- Cas Number:
- 135590-91-9
- Molecular formula:
- C16H18Cl2N2O4
- IUPAC Name:
- diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate
Constituent 1
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 breed
- Age at study initiation: approx. 3 - 5 months
- Weight at study initiation: 3.4 - 4.2 kg
- Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum, and hay (approx. 15 g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic
water dispensers, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes served as controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48, 72 h
- Number of animals or in vitro replicates:
- 6 (5 females, 1 male)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, physiological saline
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.38
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The test substance caused effects in the eyes in the form of conjunctival reddening, chemosis and discharge, inflammation and opacity of the iris, ranging in degree from slight to moderate. All signs of irritation were completely reversible within 72 hours.
- Other effects:
- No clinical signs of systemic toxicity were observed.
Any other information on results incl. tables
Means (24 - 72 hours) of individual eye irritation scores:
Animal # |
Cornea opacity (max. 4) |
Iris (max. 2) |
Conjunctiva redness (max. 3) |
Conjunctiva chemosis (max. 4) |
1 |
0 |
0 |
0.33 |
0 |
2 |
0.33 |
0 |
1.00 |
0 |
3 |
0.33 |
0 |
0.66 |
0 |
4 |
0.66 |
0.33 |
0.66 |
0 |
5 |
0.66 |
0.33 |
1.33 |
1.00 |
6 |
0.33 |
0 |
1.00 |
1.00 |
Mean |
0.38 |
0.11 |
0.83 |
0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: Not classified
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