2-Butenoic acid, 4,4,4-trifluoro-3-(methylamino)-, ethyl ester, (2Z)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate

EC Number:

801-277-8

Cas Number:

507448-65-9

Molecular formula:

C7H10F3NO2

IUPAC Name:

ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL Biological Research Laboratories, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: Young adult (approximately 7 -11 weeks)
- Weight at study initiation: 173 - 225 g
- Fasting period before study: fasted overnight prior to dosing
- Housing: 3 same-sex animals per cage
- Diet : ad libitum:
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
Date of termination of in-life phase: 200 mg/kg - January 27, 1999 (females)
2000 mg/kg - February 2, 1999 (females)
2000 mg/kg - February 5, 1999 (males)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % (w/v) in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/kg (females), 2000 mg/kg (both sexes)
200 mg/kg: 203 mg test article with vehicle ad 10 ml
2000 mg/kg: 2007 mg test article with vehicle ad 10 ml
2000 mg/kg: 2006 mg test article with vehicle ad 10 ml
- Volume applied: 10 ml/kg

DOSAGE
- Frequency of administration: One single dose

Doses:

One single dose

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Period of observation: 14 days

- Clinical observations: Checked and recorded individually at 1, 3 and 5 hours after dosing, then daily for the duration of the
observation period.

- Mortality: Checked twice daily, morning and afternoon.

- Body weight: Measured and recorded immediately before dose administration, then on days 7 and 14.

- Necropsy of survivors performed: Yes. If animals were found dead or sacrificed in extremis, they were necropsied as soon as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One male in the 2000 mg/kg group was found dead 4 days after treatment and one female in the 2000 mg/kg group was found dead 1 day after treatment.

Clinical signs:

other: There were no in-life observations indicating treatment related systemic effects for any animal in the 200 mg/kg group. Ventral recumbency was seen in all animals in the 2000 mg/kg groups on the treatment day. Hypoactivity of various intensity was seen

Gross pathology:

Necropsy examinations revealed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The following acute oral LD50 values were determined for CA 2455 A Intermediate of CGA 276854):

LD50 in male rats: Greater than 2000 mg/kg body weight
LD50 in female rats: Greater than 2000 mg/kg body weight
LD50 in rats of both sexes: Greater than 2000 mg/kg body weight

Executive summary:

Groups of 3 male and 3 female rats were administered a single dose of CA 2455 A (Intermediate CGA 276854) (batch no. LOT 3) by gavage at a dose levels of 200 mg/kg (females) and 2000 mg/kg (both sexes), followed by a 14 day post-treatment observation period.  

 

One male in the 2000 mg/kg group was found dead 4 days after treatment and one female in the 2000 mg/kg group was found dead 1 day after treatment. 

 

There were no in-life observations indicating treatment related systemic effects for any animal in the 200 mg/kg group. Ventral recumbency was seen in all animals in the 2000 mg/kg groups on the treatment day. Hypoactivity of various intensity was seen in all animals in the 2000 mg/kg groups on the treatment day and in all males in the 2000 mg/kg group on day 1 and 2 after treatment. Slight to moderate piloerection was seen in all males in the 2000 mg/kg group on the treatment day through day 3 after treatment and in two males through day 4 after treatment, slight piloerection was seen in 2 females in the 2000 mg/kg group on the treatment day and on day 3 after treatment in 2 males also on day 4 after treatment, and in two females in the 2000 mg/kg group on day 1 after treatment. All surviving males in the 2000 mg/kg group appeared normal by day 5 after treatment, all surviving females in the 2000 mg/kg group appeared normal by day 2 after treatment. 

 

Body weights were not affected by the treatment. 

 

Necropsy examinations revealed no observable abnormalities. 

 

The following acute oral LD50 values were determined for CA 2455 A Intermediate of CGA 276854):

 

LD50in male rats:                               Greater than 2000 mg/kg body weight

LD50in female rats:                            Greater than 2000 mg/kg body weight

LD50in rats of both sexes:                 Greater than 2000 mg/kg body weight