Registration Dossier
Registration Dossier
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EC number: 938-149-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
An in vivo eye irritation study to rabbit performed on 1,2-dichloro-1,2-difluoroethylene is reported.
According to Regulation EC No. 1272/2008, the substance does not meet the classification criteria for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- 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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vivo eye irritation study to rabbit performed on 1,2-dichloro-1,2-difluoroethylene is reported. According to test results, ethene,1,2 -dichloro-1,2 -difluoro is practically non-irritant to rabbit eyes.
Justification for classification or non-classification
According to Regulation EC No. 1272/2008, the substance does not meet the classification criteria for eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
