3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)-hexane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

T-7145

IUPAC Name:

T-7145

Details on test material:

- Name of test material (as cited in study report: T-7145
- Physical state: Clea colorless liquid
- Analytical purity: Expected to be >99.5%
- Lot/batch no.: Lot 4
- Expiration date of the lot/batch: April 28, 2000
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland
- Age at study initiation: approx 6 weeks old
- Fasting period before study: overnight (max 20 hours)
- Housing:- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx 21 C
- Humidity (%): approx 50%
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12 light/12 dark
IN-LIFE DATES: From: To: Females: July 13, 1999 to July 27, 1999; Males: July 15, 1999 to July 29, 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (1.2 ml/kg)

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing:Observed twice daily; Weighed pre-administration, day 8, day 15, and death
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured

Clinical signs:

other: No clinical signs of toxicity were noted

Gross pathology:

No abnormalities were found at macroscopic post motem examination of the animals

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Oral LD50 exceeds 2000 mg/kg body weight Criteria used for interpretation of results: EU

Conclusions:

LD50 is greater than 2000 mg/kg and no classification is necessary.

Executive summary:

An assessment of acute oral toxicity of the test material was conducted according to Acute Toxic Class Method. Test material was administered by oral gavage at 2000 mg/kg body weight. No mortality, signs of clinical toxicity or macroscopic changes occurred. The oral LD50 of T-7145 was established to exceed 2000 mg/kg in Wistar rats. Under Guidelines in Commission Directive 93/21/EEC, T-7145 does not have to be classified and has no obligatory labelling requirement for oral toxicity.