Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 February 2007 to 11 April 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Guideline-conform study under GLP without deviations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane
EC Number:
219-094-1
EC Name:
1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane
Cas Number:
2356-53-8
Molecular formula:
C3Cl2F6O
IUPAC Name:
1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane
Constituent 2
Reference substance name:
Methylic Adduct
IUPAC Name:
Methylic Adduct
Details on test material:
- Name of test material (as cited in study report): Methilic Adduct
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: 99.71%
- 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.: 221106
- Expiration date of the lot/batch: 31 December 2010
- Stability under test conditions: not reported
- Storage condition of test material: the test item was stored in the original, tighly closed container, at room temperature (accepted range 15-25 °C), protected from direct sunlight.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Sampling was performed 4 time during the inhalation exposure.
Duration of exposure:
4 h
Concentrations:
21.98 mg/L air
No. of animals per sex per dose:
5 (5 mals + 5 females)
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
21.98 mg/L air (analytical)
Based on:
act. ingr.
Exp. duration:
4 h

Any other information on results incl. tables

Mortality

No spontaneous deaths occurred in this study. All animals were sacrificed as scheduled on test day 15.

Clinical signs

Examination of each animal during and after exposure did not reveal any clinical signs during the 15-day observation period.

Body weights

There were no adverse effects on body weight in male animals and no relevant adverse effects on body weight in female animals during the 15-day observation period. Transient body weight loss, marginal in degree, was seen in female no. 6 (– 0.6% weight loss) and slight retardation in body weight gain in female no. 10 (+0.6% weight gain) over the first three days following the inhalation exposure (test days 1 to 4). Normal body weight gain was evident in these two females during the remainder of the 15-day observation period and in all other animals during the whole observation period. The above mentioned minor effect on female body weight in two animals was considered to be toxicologically irrelevant, because it was only transient, marginal in degree, and may have been related to slight physical stress during restraint in the exposure tube and/or incidental.

Macroscopical findings

The only macroscopic finding noted in this study was that of incompletely collapsed lungs in one female animal (no. 5). This finding was not attributed to the treatment with the test item, as there was only one incidence. Examination of each other animal on the scheduled day of necropsy (test day 15) did not reveal any macroscopic findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP-Regulation (EC) No 1272/2008
Conclusions:
The LC50 of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane for acute inhalation toxicity (4h) in male and female rats observed for a period of 15 days was estimated to be greater than 21.98 mg/L air.
Executive summary:

The purpose of this study was to assess the acute inhalation toxicity of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane when administered to rats for a single 4 -hour period.

A group of five male and five female albino rats was exposed by nose-only, flow-past inhalation to the test item at a chemically determined mean atmosphere concentration of 21.98 mg/L air, equivalent to a nominal concentration of 25.91 mg/L air. All animals were observed for clinical signs and mortality during and following the inhalation exposure, i.e. over a 15 -day observation period. Body weights were recorded prior to exposure on test day 1, and during the observation period an test days 4,8, and 15. On day 15 all animals were sacrificed and necropsied.

The ranges of temperature, relative humidity, oxygen content and airflow of the test atmosphere were considered to be satisfactory for a study of this type. Measurement of particle size of the test atmosphere by the use of a cascade impactors was inappropriate, because vistually all of the nebulised test item was readily evaporating at the atmosphere concentration tested.

There were no deaths, no clinical signs, no relevant adverse effects on body weight, and no macroscopic pathology findings attributable to the treatment with the test item.

In conclusion, the LC50 of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane for acute inhalation toxicity (4h) in male and female rats observed for a period of 15 days was estimated to be greater than 21.98 mg/L air (chemically determined mean atmosphere concentration equivalent to a nominal atmosphere concentration of 25.91 mg/L air).