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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1996
Deviations:
no
Remarks:
No deviations ocurred that impacted the integrity of the study.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-BUTANESULFONAMIDE, 1,1,2,2,3,3,4,4,4-NONAFLUORO-N-METHYL-
EC Number:
614-396-3
Cas Number:
68298-12-4
Molecular formula:
C5H4F9NO2S
IUPAC Name:
1-BUTANESULFONAMIDE, 1,1,2,2,3,3,4,4,4-NONAFLUORO-N-METHYL-
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
3M Company, Lot 3
- Expiration date of the lot/batch:
06 August, 2002
- Purity test date:
30 January, 2002

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature in the dark.
- Stability under storage conditions:
Stable
- Stability under test conditions:
Stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium:
The test article was tested as a suspension in propylene glycol.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
The test article was suspended in propylene glycol.
- Final preparation of a solid:
Suspended in propylene glycol.

FORM AS APPLIED IN THE TEST: The test article was suspended in propylene glycol.

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
- Females (if applicable) nulliparous and non-pregnant:Yes
- Rationale for use of males: Males and females were utilized.
- Age at study initiation: 6-9 weeks
- Weight at study initiation: Females: 202-222 g, Males: 333-357 g
- Fasting period before study: Food was withheld overnight (max 20 hours0 prior to dosing and until approximately 3-4 hours post-dose.
- Housing: Group housing of 3 animals per sex per cage in labelled Macrolon cages.
- Diet (e.g. ad libitum): Pelleted lab animal diet (Altromin) ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: No data
- Microbiological status when known : No data
- Method of randomisation in assigning animals to test and control groups: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 04 September, 2001, To:28 September, 2001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Propylene glycol
Remarks:
Propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: Dosing solutions were prepared to properly dose animals with 2000 mg/kg or 200 mg/kg at a maximum dose volume of 10 mL/kg.
- Amount of vehicle (if gavage): Maximum dose volume was 10 mL/kg
- Justification for choice of vehicle: Test article compatibility
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:
2000 or 200 mg/kg.
No. of animals per sex per dose:
3 females were dosed at 2,000 mg/kg and 3 males and 3 females were dosed at 200 mg/kg.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at 0, 2, and 4 hours postdose and once daily thereafter for 14 days. Body weights wererecorded at pre-test, weekly, and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination upon necropsy.
Statistics:
No data

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
200 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Twofemales (2/3; 67%) treated at 2000 mg/kg were found dead on Day 2.
Clinical signs:
Twofemales (2/3; 67%) treated at 2000 mg/kg were found dead on Day 2. Lethargy, hunched posture, and uncoordinated movements were observed in theseanimals prior to death. In addition to these observations, piloerection and chromodacryorrhea was noted in the surviving 2000 mg/kg-treated female. All 200mg/kg-treated animals survived. Lethargy was observed on Days 1 and 2 in 200 mg/kg-treated females. Lethargy and uncoordinated movements wereobserved on Days 1 and 2 in 200 mg/kg-treated males.
Body weight:
There were not abnormal body weight changes observed in the surviving treated animals.
Gross pathology:
No abnormal findings were observed upon necropsy.
Other findings:
- Organ weights: Not examined.
- Histopathology: Not examined.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on the results of this study, the oral LD50 of the test article is greater than 200 but less than 2000 mg/kg.
Executive summary:

The acute oral toxicity of the test article (off white solid, Lot 3) was evaluated in Wistar rats. This studywas performed in compliance with OECD GLP. The study method was based on OECD 423 (1996) and Commission Directive 96/54/ECAn IV B.1 (1996).The test material was prepared in propylene glycol just prior to dosing.Initially, 3 female rats received a single dose of 2000 mg/kg via oralgavage at a dose volume of 10 mL/kg.Since mortality was observed at this dose level, additional rats (3/sex) received a single dose of 200 mg/kg via oralgavage at a dose volume of 10 mL/kg.The rats were observed at 0, 2, and 4 hours post dose and once daily thereafter for 14 days.Body weights wererecorded at pre-test, weekly, and at termination.After the observation period, all animals were euthanized and examined for gross pathology. Twofemales (2/3; 67%) treated at 2000 mg/kg were found dead on Day 2.Lethargy, hunched posture, and uncoordinated movements were observed in theseanimals prior to death.In addition to these observations, piloerection and chromodacryorrhea was noted in the surviving 2000 mg/kg-treated female.All 200mg/kg-treated animals survived.Lethargy was observed on Days 1 and 2 in 200 mg/kg-treated females.Lethargy and uncoordinated movements wereobserved on Days 1 and 2 in 200 mg/kg-treated males.There were no abnormal body weight changes or necropsy findings. Based on theresults of this study, the oral LD50 of the test article is greater than 200 but less than 2000 mg/kg.