N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 Mar 2017 to 29 Mar 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

No. 440/2008

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide

EC Number:

279-481-6

EC Name:

N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide

Cas Number:

80475-32-7

Molecular formula:

C13H17F13N2O3S

IUPAC Name:

N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide

Specific details on test material used for the study:

Purity: 96.7%

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RCCHanTM :WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 173 to 199 g at day 0
- Fasting period before study: An overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study
- Diet: 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK (ad libitum)
- Water: mains drinking water (ad libitum)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

as a flowable gel in distilled water

Details on oral exposure:

TEST ITEM PREPARATION
- The test item was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
- No analysis was conducted to determine the homogeneity, concentration or stability of the test item formulation.
- Concentration in vehicle: 30 mg/mL and 200 mg/mL corresponding to dose-levels of 300 and 2000 mg/kg bw

DOSE VOLUME APPLIED:
10 mL/kg, calculated according to the fasted body weight at the time of dosing.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

- At first, 1 animal was treated with 300 mg/kg bw
- In the absence of toxicity, another animal was treated with 2000 mg/kg bw
- In absence of mortality, 4 additional animals were treated with 2000 mg/kg bw

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made 30 minutes, 1, 2 and 4 hours after dosing and then daily. Individual body weights were recorded on Day 0 (the day of dosing) and on days 7 and 14.
- Necropsy of survivors performed: yes, At the end of the observation period the animals were killed by ascending concentrations of carbon dioxide, death was then confirmed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality in any of the treatment groups.

Clinical signs:

- 300 mg/kg bw: No signs of systemic toxicity were noted during the observation period.
- 2000 mg/kg bw: Hunched posture was noted 2 and 4 hours after dosing in the initial treated animal. No signs of systemic toxicity were noted during the observation period in the four additional treated animals.

Body weight:

- 300 mg/kg bw: The animal showed expected gains in body weight over the observation period.
- 2000 mg/kg bw: Animals showed expected gains in body weight over the observation period except for one animal which showed body weight loss during the first week with expected gain in body weight during the second week.

Gross pathology:

No abnormalities were noted at necropsy in any of the treatment groups.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity test showed an LD50 > 2000 mg/kg bw

Executive summary:

The acute oral toxicity of the test substance was assessed according to the Fixed dose Method (OECD guideline 420) and GLP principles. In this study one female Wistar (RCCHanTM :WIST) rat was dosed with 300 mg/kg bw test substance by gavage. Since no toxicity was observed, an additional female was treated with 2000 mg/kg bw and subsequently, since no mortality occurred, 4 additional females were treated at this dose. During the 14 day observation period no mortality was observed. Clinical signs were only observed in the first animal dosed at 2000 mg/kg bw: a hunched posture was noted 2 and 4 hours after dosing in this animal. No signs of systemic toxicity were noted during the observation period in the four additional treated animals. All animals showed expected gains in body weight over the observation period except for one animal in the 2000 mg/kg bw dose group which showed body weight loss during the first week with expected gain in body weight during the second week. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be above 2000 mg/kg bw. Based on these results, the test substance is not considered to be acutely harmful.