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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:
other: Guideline-conform study under GLP without deviations.

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

Constituent 1
Reference substance name:
1,2-dichloro-1,2-difluoroethylene
EC Number:
209-956-5
EC Name:
1,2-dichloro-1,2-difluoroethylene
Cas Number:
598-88-9
IUPAC Name:
1,2-dichloro-1,2-difluoroethene
Constituent 2
Reference substance name:
27156-03-2
EC Number:
608-056-3
Cas Number:
27156-03-2
IUPAC Name:
27156-03-2
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 applicable
- Isomers composition: not reported
- Purity test date: not reported
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: stored at ambient temperature in the company dispensary of the research centre.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
20 mg/litre
No. of animals per sex per dose:
5 males + 5 females
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating conc.
Effect level:
20 mg/L air
Based on:
test mat.
Exp. duration:
4 h

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 durign 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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.