3,4,5-trifluorophenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 26, 2000 - September 28, 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

March 22, 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

September 30, 1996

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,4,5-trifluorophenol

EC Number:

436-120-9

EC Name:

3,4,5-trifluorophenol

Cas Number:

99627-05-1

Molecular formula:

C6H3F3O

IUPAC Name:

3,4,5-trifluorophenol

Test animals

Species:

rat

Strain:

other: HsdCpb: WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen
- Age at study initiation: about 6 to 8 weeks
- Weight at study initiation: 172 (range from 159 to 181) g
- Fasting period before study: Diet was withheld from about 17 hours before dosing up to 4 hours after treatment.
- Housing: separately in Makrolon cages type HI with a shelter
- Diet: ad libitum, LONG LIFE for mice and rats 9439, Eberle Nafag)
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 28
- Humidity (%): 50 to 66
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methocef K4M Premium solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 1.25, 10, 100 g/L

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

25, 200, 2000 mg/kg bw

No. of animals per sex per dose:

3 (see table1)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The behavior and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily. All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 200 - <= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the highest dose died within a few minutes after administration.

Clinical signs:

Signs of toxicity were seen from 1 to 15 minutes up to day 3 after administration.
2000 mg/kg bw (f): lateral position, motor excitation, and dyspnea.
200 mg/kg bw (m + f): abdominal and dorsal position, lococmotor disturbance, and dyspnea.
25 mg/kg bw(m): locomotor disturbance was the only symptom.

Body weight:

Body weight development of the surviving rats was inconspicuous.

Gross pathology:

At pathology all rats which died showed mild local changes in the gastro intestinal tract. All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

According to the results of this study the LD50 value is expected between 200 - 2000 mg/kg bw.

Executive summary:

A study according OECD TG 423 (Acute Class Method) was performed to determine the acute oral toxicity of the test item. The test material was administered by oral gavage using doses of 25, 200, and 2000 mg/kg body weight. Directly before the administration the test material was prepared with aqueous Methocel® K4M Premium solution as vehicle.

Signs of toxicity were seen from 1 to 15 minutes up to day 3 after administration. In females of the 2000 mg/kg be dose group lateral position, motor excitation, and dyspnea was reported.

In all animals of the 200 mg/kg bw dose group abdominal and dorsal position, locomotor disturbance, and dyspnea was detected. In the 25 mg/kg bw dose group males showed locomotor disturbance.

All animals of the highest dose died within a few minutes after administration. Body weight development of the surviving rats was inconspicuous.

At pathology all rats which died showed mild local changes in the gastro intestinal tract. All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.

According to the results of this study the LD50 value is expected between 200 - 2000 mg/kg bw.