Registration Dossier

Administrative data

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.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1087

Materials and methods

Test guideline
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

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): Ethane,1,2-dichloro-1,1,2-trifluoro-2-trifluoromethoxy
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: not reported
- 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.: F104206
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: in the dark under ambient conditions.

Test animals

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

Administration / exposure

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

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
act. ingr.

Any other information on results incl. tables

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.

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 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.