1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methylbutane-1-sulphonamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 September 2001 to 20 September 2001 (dates of study plan)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EC Council Directive 67/548/EEC, Annex V, Part B; Dutch Act on Animal Experimentation

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

T-7599

IUPAC Name:

T-7599

Details on test material:

- Name of test material (as cited in study report): T-7599
- Substance type: White powder
- Analytical purity: >99.9% 1-Butanesulfonamide, 1, 1, 2, 2, 3, 3, 4, 4, 4-Nonafluoro-n-(2-Hydroxyethyl)-N-Methyl; < 0.1% Methylamine.
- Lot/batch no.: Lot 6
- Expiration date of the lot/batch: 07 August 2002
- Stability under test conditions: Not indicated
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: Females-mean 187 g/ Males-mean 298 g
- Fasting period before study: overnight for a maximum of 20 hours
- Housing:- 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 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark.
IN-LIFE DATES: From: 04 September 2001 To: 20 September 2001.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Polyethylene glycol 400 (specific gravity 1.125)

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at NOTOX.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight.

Doses:

Single dose at 2000 mg/kg body weight.

No. of animals per sex per dose:

3 animals per sex per dose.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Body weights measured on days 1, 8 and 15. Observations for mortality were made twice daily.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Clinical signs were observed at periodic intervals on the day of dosing and once daily thereafter, until day 15.

Statistics:

No statistical method was performed (this method not intended to allow the calculation of a precise LD50 value.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured.

Clinical signs:

other: Lethargy, uncoordinated movements, hunched posture and/or chromodacryorrhoea were noted among the females between days 1 and 3. Lethargy and uncoordinated movements were noted among the males between days 1 and 2.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value for T-7599 in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

An assessment of acute oral toxicity with the test article in female and male Wistar rats was employed using the acute toxic class method. The study was carried out based on OECD 423 and the EC Commission Directive 96/54/EC, Part B.1. The test article was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality occurred. Lethargy, uncoordinated movements, hunched posture and/or chromodacryorrhoea were noted among the females between days 1 and 3. Lethargy and uncoordinated movements were noted among the males between days 1 and 2. The mean body weight gain shown by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 values of the test article in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test article does not have to be classified and has no obligatory labelling requirement for oral toxicity.