Ethane, 1,1,2-trichloro-1-fluoro-2-(trifluoromethoxy)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 July 1995 to 2 August 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (1R)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether and (1S)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether

EC Number:

938-115-1

Cas Number:

94720-90-8

Molecular formula:

C3HCl3F4O

IUPAC Name:

Reaction mass of (1R)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether and (1S)-1,2,2-trichloro-2-fluoroethyl trifluoromethyl ether

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): ADDOTTO TRIELINA
- Analytical purity: > 98%
- Lot/batch No.: 18852-1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Livestock
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Males: 225-250 g, Female: 200-225 g
- Fasting period before study: 16 hours. Feed was returned to rats three hours after the test article administration.
- Housing: 5 animals/sex/cage in T11 air conditioned room.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Five days before the start of the test. Animals were observed daily to ascertain their fitness for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-2
- Humidity (%): 55 +- 10
- Air changes (per hr): about 20/hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m.- 7 p.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted
- Amount of vehicle (if gavage): The volume of administration was 1.26 ml/kg in order to obtain the dose of 2000 mg/kg being the density 1.587 g/ml.
- Justification for choice of vehicle: not applicable

MAXIMUM DOSE VOLUME APPLIED: 1.26 mL/Kg bw corrisponding to 2000 dose mg/Kg bw

Doses:

2000 mg/ kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations of clinical signs: at 30 minutes, 2, 4 and 6 hours on the first day after the administration (day 1) and then twice a day up to termination of the observation period.
- Body weighing: twice pre-trial (at randomization and on day 1 just before administration) and on days 3, 8 and 14. On day 1 the animals were weighted after 16-hour fasting. Volume of administration was based oh day 1 body weight.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology examination.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study. The LD50 was not calculated and it was considered higher than 2000mg/kg.

Clinical signs:

other: No clinical signs or behavioral alterations were observed in any animal during the observation period.

Gross pathology:

At the autopsy carried out at the end of the observation period no appreciable macroscopic findings were evident in any treated rats.

Other findings:

none.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

CLP criteria

Conclusions:

The LD50 of the test article, when administered to rats as a single dose by oral route, is higher than 2000 mg/kg bw.

Executive summary:

 Experimental data from a toxicity study in which Sprague Dawley rats received a single oral administration of the test article at the dosage of 2000 mg/kg bw (5 males and 5 females) are given in this report.

The test method was in accordance with European Economic Community Guidelines B.1 and with OECD guidelines 401.

The test article was administered undiluted at the volume of 1.26 ml/kg in order to give the dose of 2000 mg/kg being the density 1.587 g/ml.

All rats were treated after a 16 hours fasting period. The day of treatment was considered day 1 of the study. The animals were weighted twice before treatment (at randomization and on day 1 just before treatment) and on day 3, 8 and 14. They were clinically observed for 14 days following the treatment. On day 15 all rats were killed (fasted overnight) and submitted to a thorough autopsy.

No animals died during the study. The LD50 was higher than 2000 mg/kg bw.

All treated rats did not show any clinical signs or behavioral alterations during the post-treatment observation period.

Body weight resulted unaffected by treatment.

At the autopsy carried out at the end of the observation period no appreciable macroscopic findings were evident in any treated rat.