2,2,2-trifluoroethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed accordingly to the OECD Guideline No. 401 and in accordance to the GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

: no information on the purity of the test substance.

Principles of method if other than guideline:

not applicable.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,2-trifluoroethanol

EC Number:

200-913-6

EC Name:

2,2,2-trifluoroethanol

Cas Number:

75-89-8

Molecular formula:

C2H3F3O

IUPAC Name:

2,2,2-trifluoroethan-1-ol

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: male: 122-145g; female: 108-121g
- Fasting period before study: yes
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 15%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: unspecified

Doses:

60, 125, 250, 500 and 1000 mg/kg bw.

No. of animals per sex per dose:

5 rats/sex/dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: clinical sign observation at 15, 30, 60, 180, 360 min and then every days. Weighing at day 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, gross pathology.

Statistics:

LD50 was determined for the male rats according to the Probit method whereas for the female rats LD50 is determined according to the Van der Waerden method.

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

153 mg/kg bw

95% CL:

>= 102 - < 232

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

177 mg/kg bw

Mortality:

Yes: see details in Table 7.2.1/2.

Clinical signs:

other: In the dead rats, the male and females of the 250, 500 and 1000 mg/kg groups decline in spontaneous movement, and have an abnormal gait, an irregular respiration (bradypnea), lacrimation, soiled perineal position (only for 500 and 1000 mg/kg dose groups)

Gross pathology:

Swollen abdomens from hemorrhaging or water retention in the glandular stomach or forestomach were observed in a large portion of the dead rats. Other changes that were observed are shrinking of the thymus in the 250 mg/kg group, pulmonary congestion in low-dose groups over 250 mg/kg and tar contents in the jejunum/ileum or appendix in 1000 mg/kg groups. No abnormalities were seen for in the survival animals during the autopsy.

Other findings:

no data

Any other information on results incl. tables

Table 7.2.1/2: Mortality after an oral administration of 2,2,2 Trifluoroethanol

Dose (mg/kg)	Mortality (# dead/total)			Time range of death
	Male	Female	Combined
60	0/5	0/5	0/10	-
125	1/5	0/5	1/10	Day 2
250	5/5	5/5	10/10	Day 2 (4 males and 2 females), Day 3 (3 females), Day 4 (1 male)
500	5/5	5/5	10/10	Day 2 (4 males), Day 3 (1 male and 5 females)
1000	5/5	5/5	10/10	Day 2 (5 males and 2 females), Day 3 (3 females)

 

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

With an oral acute DL50 between 50 and 300 mg/kg, under the test conditions, 2,2,2-trifluoroethanol is classified in category 3 (Toxic by ingestion, H301) according to the annex VI of the 1272/2008 CLP.

Executive summary:

In an acute oral toxicity study, performed according to the OECD guideline No. 401 (1987), and in compliance with the GLP, groups of Crj:CD(SD) male and female rats (5 animals/sex/dose) were given a single oral dose of 2,2,2-trifluoroethanol (TFE) at doses of 60, 125, 250, 500 and 1000 mg/kg bw. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days.

Oral LD₅₀in male rats = 153 mg/kg bw, Oral LD₅₀in female rats = 177 mg/kg bw

Death occured rapidly after TFE administration (from day 2). Dead animals presented severe toxic effects such as a decrease in locomotor activity, an abnormal gait, an irregular respiration (bradypnea), lacrimation, soiled perineal position (only for 500 and 1000 mg/kg dose groups) and a prone position. These effects were visible within the day 2 in the 250 and 500 mg/kg bw dose groups and 30 min after the TFE administration in the 1000 mg/kg bw dose group. Furthermore, swollen abdomens from hemorrhaging or water retention in the glandular stomach or forstomach were observed in a large portion of the dead rats. Other changes that were observed are shrinking of the thymus. Survival animals presented no abnormalities.

Under the test conditions, 2,2,2-trifluoroethanol is classified in category 3 (Toxic by ingestion, H301) according to the annex VI of the 1272/2008 CLP.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.