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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.