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Description of key information

An oral toxicity study and an inhalation toxicity study, performed on 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane are reported.
No signs of tocixity were observed under the reported studies.
According to Regulation EC No. 1272/2008, the substance does not meet the classification criteria both for oral and inhalation acute toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1987 to 13 August 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Dose ranging study: 100, 500, 1000, 3000, 5000 mg/kg
Main study: 5000 mg/kg
No. of animals per sex per dose:
Dose ranging study: 1 male and 1 female per dose
Main study: 5 males + 5 females at 5000 mg/kg
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.

Dose ranging

No deaths and no clinical signs were noted during the 14 day observation period.

Main study

There were no deaths.

Clinical signs were limited to piloerection noted at 1 -4 hours after dosing.

At post mortem, gross examination revealed no abnormalities.

Body weight gains are within the acceptable range.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP-Regulation (EC) No 1272/2008
Conclusions:
The median lethal dose (LD50) of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is greater than 5000 mg/kg bw.
Executive summary:

The IRI project No.238237, includes an acute oral toxicity test, an eye irritation test and a dermal irritation test.

In the acute oral toxicity test in rats, no deaths occurred and mild transient clinical signs were noted following a single oral dose of

1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane at a dose level of 5000 mg/kg bw (vehicle: corn oil).

The median lethal dose (LD50) of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw

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

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.

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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
21 980 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

An oral toxicity study and an inhalation toxicity study, performed on 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane are reported.

Under the acute oral toxicity study the LD 50 (male and female rats) of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane was determined to be greater than 5000 mg/kg bw.

Under the acute inhalation toxicity study the LC50 (4h exposure, male and female rats) of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane was estimated to be greater than 21.98 mg/L air.

Justification for classification or non-classification

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