1,2-dichloro-1,2-difluoroethylene

Acute Toxicity: inhalation

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

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

Reference

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.
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.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

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

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

discriminating conc.

Effect level:

20 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 20 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Effect levels 3

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

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.