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Description of key information

Acute toxicity study by inhalation (OECD guideline 403, GLP):
Rat (males and females) LC50 > 20 mg/L (no mortality at that concentration), i.e. LC50 > 20000 ppmV

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 September 1987 to 10 October 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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.
The chemical name was sometimes associated with CAS 598-88-9.
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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
inhalation: gas
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
20 mg/litre (i.e. 20000 ppmV)
No. of animals per sex per dose:
5 males + 5 females
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: see below
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: gross pathology
Key result
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
20 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 20 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 20 000 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: test atmosphere: gaseous
Mortality:
None
Clinical signs:
lethargy (hypoactivity)
Body weight:
No specific effect on body weight gain
Gross pathology:
No abnormal findings

The animals exposed to ethene,1,2 -dichloro-1,2 -difluoro appeared slightly sedated and less responsive to audio stimuli (e.g. tapping on chamber wall) during exposure than the control animals.


No abnormalities were observed during the subsequest 14-day observation period.


No effect on body weight gain were observed following exposure to ethene,1,2-dichloro-1,2-difluoro. Body weight profiles were considered to be satisfactory.


At post mortem examination no gross pathological abnormalities were observed.

Interpretation of results:
GHS criteria not met
Conclusions:
No evidence of toxicity was observed following a 4hours exposure to air containing 20 mg/litre of ethene,1,2-dichloro-1,2-difluoro.
Executive summary:

The study was undertaken to investigate the acute inhalation toxicity of ethene,1,2 -dichloro-1,2,difluoro in rats following a single 4 h whole body exposure. The study was conducted as a limit test in compliance with OECD guidelines for acute toxicity testing.

One group of 5 males and 5 females of albino rats, Sprague-Dawley descended, was exposed to air containing 20 mg/litre of the test substance.

There were no mortalities and no reactions to treatment were observed. No gross abnormalities were observed following necropsy at the end of the 14 days observation period. In conlusion, no evidence of toxicity was observed under test conditions.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 20 000 ppm air
Physical form:
inhalation: gas

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An acute toxicity study by inhalation, performed on 1,2-dichloro-1,2-difluoroethylene according to OECD guideline 403 is reported.


No evidence of toxicity was observed in rats following a 4-hour exposure to air containing 20 mg/litre of the test item (i.e., 20 000 ppmV).

Justification for classification or non-classification

According to Regulation EC No. 1272/2008, the substance does not meet the classification criteria for acute toxicity by inhalation.