Registration Dossier
Registration Dossier
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EC number: 603-525-9 | CAS number: 131860-97-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991 - 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Summary report signed by the study director of the original GLP study, plus one internal reviewer. The toxicological information contained in the report was derived from studies which fulfill the requirements of GLP. The report format does not give all information required by the guideline: some experimental details and individual data were not provided.
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Not explicitly stated
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- Confirmed by study director
Test material
- Reference substance name:
- Benzeneacetic acid, 2-[(6-chloro-4-pyrimidinyl)oxy]-α-(methoxymethylene)-, methyl ester, (αE)-
- IUPAC Name:
- Benzeneacetic acid, 2-[(6-chloro-4-pyrimidinyl)oxy]-α-(methoxymethylene)-, methyl ester, (αE)-
- Reference substance name:
- 603-525-9
- EC Number:
- 603-525-9
- Cas Number:
- 131860-97-4
- Molecular formula:
- C15H13ClN2O4
- IUPAC Name:
- 603-525-9
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
VEHICLE
- Amount(s) applied (volume or weight with unit): No data - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- Days 1, 2, and 3
No data on later observations - Number of animals or in vitro replicates:
- 3
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
- Reversibility:
- not specified
- Remarks on result:
- other: All animals scored 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other: All animals scored 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.45
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 15
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 13
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 14
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 15
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Initial pain reaction (IPR) = Practically none to slight (class 1-2 on a scale of 0-5)
Any other information on results incl. tables
Mild irritant (class 4 on a scale of 1 -8)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- For this endpoint the summarised result of one study (CTL, Robinson) is available, which was conducted under GLP.
While the full study report is not available, the results are sufficiently detailed and unambiguous as to be suitable for classification and labeling.
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