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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
Reference
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.

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.