2,2,2-trifluoroethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1985-05-17 to 1985-06-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2,2-trifluoroethyl methacrylate

EC Number:

206-525-3

EC Name:

2,2,2-trifluoroethyl methacrylate

Cas Number:

352-87-4

Molecular formula:

C6H7F3O2

IUPAC Name:

2,2,2-trifluoroethyl methacrylate

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): MATRIFE

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: approx. 4 to 6 weeks
- Weight at study initiation: 95-125 g (males), 103-118 g (females)
- Fasting period before study: yes; overnight prior to and approx. 2 h after dosing
- Housing: in groups of 5 by sex in polypropylene cages with sawdust bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 45-66%
- Air changes (per hr): approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2.5, 20, 200, 500 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

pretest: 25, 200, 2000, 5000 mg/kg bw
main study: 200 mg/kg bw

No. of animals per sex per dose:

pretest: 2
main study: 5

Control animals:

no

Details on study design:

- Duration of observation period following administration: pretest: 5 days; main study: 14 days
- Frequency of observations: pretest: 1/2, 1, 4 h, once daily for 5 days; main study: 1/2, 1, 2, 3, 4, 5 h, daily at least once for 14 days
- Frequency of weighing: main study: day 0, 7, 14
- Necropsy of survivors performed: main study: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

- in the pretest 0/4 animals died at dose levels of 25 and 200 mg/kg bw; 4/4 animals died at dose levels of 2000 and 5000 mg/kg bw
- in the main study 0/10 animals died at 200 mg/kg bw

Clinical signs:

Pretest
25 mg/kg bw
- hunched posture and piloerection
- recovery on day 1

200 mg/kg bw
- hunched posture and piloerection
- lethargy
- decreased respiratory rate
- recovery on day 1

2000 mg/kg bw
- hunched posture and piloerection
- lethargy
- comatose conditions
- decreased respiratory rate

5000 mg/kg bw
- hunched posture and piloerection
- lethargy
- comatose conditions

Main study
200 mg/kg bw
- hunched posture and piloerection
- in soma rats only: lethargy, ptosis, diarrhoea, decreased respiratory rate
- recovery within 2 days

Body weight:

Main study
No significant effects on body weight gain were observed during the study.

Gross pathology:

Main study
No abnormalities were observed at terminal necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The oral LD50 of TFMEA in rats was >200 mg/kg bw and <2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study according to OECD guideline 401, groups of fasted, 4-6 weeks old Sprague-Dawley rats (2/sex) were given a single oral dose of TFMEA (purity not given in the study report, but according to sponsor >90%) at dose levels of 25, 200, 2000, 5000 mg/kg bw in Arachis oil and observed for 5 days.

0/4 animals died at dose levels of 25 and 200 mg/kg bw; 4/4 animals died at dose levels of 2000 and 5000 mg/kg bw.

Hunched posture and piloerection were observed at all dose levels. Additionally, lethargy and decreased respiratory rate were observed in the 200 mg/kg bw dose group. Animals of the 25 and 200 mg/kg bw dose group had recovered on day 1.

In the 2000 and 5000 mg/kg bw dose group lethargy and comatose conditions were noted, a decreased respiratory rate only in the 2000 mg/kg bw dose group.

 

Based on these results, the main study was performed with 5 rats/sex at 200 mg/kg bw in Arachis oil. Animals were observed for 14 days.

No mortalities occurred during the observation period. Clinical signs were hunched posture and piloerection. In soma rats lethargy, ptosis, diarrhoea and decreased respiratory rate were noted. All animals had recovered within 2 days.No significant effects on body weight gain were observed during the study. No abnormalities were observed at terminal necropsy.

The oral LD50 (rat; male/female) of TFMEA was >200 mg/kg bw and <2000 mg/kg bw.