Registration Dossier
Registration Dossier
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EC number: 938-149-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 August 1987 to 7 August 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of (Z)-1,2-dichloro-1,2-difluoroethylene and (E)-1,2-dichloro-1,2-difluoroethylene
- EC Number:
- 938-149-7
- Molecular formula:
- not applicable - multi-constituent substance
- IUPAC Name:
- Reaction mass of (Z)-1,2-dichloro-1,2-difluoroethylene and (E)-1,2-dichloro-1,2-difluoroethylene
- Test material form:
- liquid
Constituent 1
- Reference substance name:
- Ethene,1,2-dichloro-1,2-difluoro
- IUPAC Name:
- Ethene,1,2-dichloro-1,2-difluoro
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Ethene,1,2-dichloro-1,2-difluoro
- Substance type: pure substance
- Physical state: liquid
- Boiling point: 22°C
- Analytical purity: > 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: not reported
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: F 285975
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: Stored in the dark under ambient conditions. - Specific details on test material used for the study:
- At the time of study, the test material was described as Ethene, 1,2-dichloro-1,2-difluoro.
As for registration purpose the full characterisation has established the substance is a mixture of 2 isomers (Z and E), it is now described as Reaction mass of (Z)-1,2-dichloro-1,2-difluoroethylene and (E)-1,2-dichloro-1,2-difluoroethylene. - Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single instillation.
- Observation period (in vivo):
- at 1, 24, 48, 72 hours after instillation.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
- Washing : no
SCORING SYSTEM: Draize scale
TOOL USED TO ASSESS SCORE: hand-slit lamp (standard illumination) - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 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
- Remarks:
- All 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (Redness)
- Basis:
- mean
- Remarks:
- All 3 animals
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Remarks:
- all 3 animals
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ethene,1,2 -dichloro-1,2 -difluoro is pratically non-irritant to rabbit eyes.
- Executive summary:
The eye irritation potential of Ethene,1,2-dichloro-1,2-difluoro was investigated in rabbits, meeting OECD guidelines.
No corneal or iridial responses were noted.
Slight conjunctival redness was noted in all treated eyes 1 h post instillation. All eyes had returned to normal at 24h post instillation.
Ethene,1,2 -dichloro-1,2 -difluoro is pratically non-irritant to rabbit eyes.
Reference
Constituent 1
Test animals / tissue source
Test system
Results and discussion
In vivo
Resultsopen allclose all
Applicant's summary and conclusion
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