1-Propanesulfonic acid, 2-methyl-2-[[1-oxo-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]propyl]amino]-, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

07 May, 2015 - 25 May, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(2001)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate

EC Number:

811-522-0

Cas Number:

62880-93-7

Molecular formula:

C15H17F13NNaO4S2

IUPAC Name:

sodium 2-methyl-2-{3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulfanyl]propanamido}propane-1-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): NS-3000
- Appearance: Off-white powder
- Storage condition of test material: At room temperature desiccated

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, NC
- Age at study initiation: Young adult animals (approx. 9 weeks old)
- Weight at study initiation: 181 to 203 g, ± 20% of the sex mean.
- Fasting period before study: Overnight prior to dosing and food was returned approximately 4 hours after dosing.
- Housing: All animals were housed individually in clean, stainless steel, wire-mesh cages suspended above cage-board.
- Diet: Free access to basal diet (PMI Nutrition International, LLC, Certified Rodent LabDiet® 5002)
- Water: Free access to municipal water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3 - 21.4
- Humidity (%): 32.1 - 59.1
- Air changes (per hr): minimum 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water

Details on oral exposure:

GAVAGE METHOD: plastic feeding tubes.

Frequency: single dosage, on Day 1.

VEHICLE:
The vehicle used in preparation of the test substance formulation was deionized water (prepared on-site). The 1N hydrochloric acid used to adjust the pH of the test substance formulation was prepared using hydrochloric acid.

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg body weight.

DOSAGE PREPARATION: On each day of dosing, a sufficient amount of test substance was weighed into a glass container. Approximately 95% of the vehicle was added. The contents were mixed using a probe sonicator at 30% amplitude in 1 minute cycles to achieve a uniform formulation.
The remaining vehicle and a stir bar were added. The pH of the dosing formulation was adjusted to 6.59 to 7.61 using 1N hydrochloric acid. The contents were stirred continuously throughout use.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 (2 groups of three females in a stepwise manner)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Approximately 15 minutes (± 5 minutes) and 1, 2 and 4 hours post-dosing on study day 0 and twice daily, once in the morning and once in the afternoon, thereafter for 14 days.
Clinical observations: Approximately 15 minutes (± 5 minutes) and 1, 2, and 4 hours post-dosing on study day 0 and once daily thereafter for 14 days.
Body weights: Body weights were obtained and recorded on study days 0 (initiation), 7, and 14 (termination).
- Necropsy of survivors performed: On study day 14, the rats were euthanized by carbon dioxide inhalation. The major organ systems of the cranial, thoracic, and abdominal cavities and the eyes and skin were examined for all animals.
- Other examinations performed: none.

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived to the scheduled necropsy (study day 14).

Clinical signs:

other: There were no clear test substance-related clinical observations. The only clinical observation was soft feces for 1 female on study day 0 (15 minutes and 4 hours post-dosing).

Gross pathology:

There were no test substance-related macroscopic findings at the scheduled necropsy. The only gross lesion observed was an enlarged pituitary gland for one female.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study with rats, performed according to OECD 423 test guideline, an LD50 >2000 mg/kg bw was determined for NS-3000.

Executive summary:

The acute oral toxicity of NS-3000 was determined in accordance with OECD 423 guideline and according to GLP principles.

NS-3000 was administered to six female rats by a single dose of 2000 mg/kg bodyweight (2 groups of three females in a stepwise manner). All animals survived to the scheduled necropsy (study day 14). There were no clear test substance-related clinical observations. The only clinical observation was soft feces for 1 female on study day 0 (15 minutes and 4 hours post-dosing). There were no remarkable body weight changes noted during the study. There were no test substance-related macroscopic findings at the scheduled necropsy. The only gross lesion observed was an enlarged pituitary gland for one female. Based on the results of this study, the estimated LD50 of NS-3000 was greater than 2000 mg/kg body weight and the substance does not need to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.