2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl methacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

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

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

17 December, 2001

Deviations:

no

Remarks:

No deviations occurred that impacted the study integrity or the validity of the study.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl acrylate

EC Number:

266-733-5

EC Name:

2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl acrylate

Cas Number:

67584-55-8

Molecular formula:

C10H10F9NO4S

IUPAC Name:

2-{methyl[(nonafluorobutyl)sulfonyl]amino}ethyl acrylate

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report:T-7600
- Physical state: solid
- Composition of test material, percentage of components: >97%2-Propenoic acid, 2-[Methyl[(nonafluorobutyl)sulfonyl]amino]ethyl ester; <2% Water, < 0.01% Phenothiazine
- Lot/batch no.: Lot 1
- Expiration date of the lot/batch: 06 August 2002
- Stability under test conditions: not indicated
- Storage condition of test material: At room temperature in the dark.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot: 40010
- Expiration date of the lot/batch: 24 May 2020
- Purity test date: 24 March 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature and in the dark
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: The test article was homogenized in the vehicle.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was homogenized in the vehicle (corn oil)

FORM AS APPLIED IN THE TEST: Homogenized in corn oil.

Test animals

Species:

rat

Strain:

other: Wistar Hannover

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Envigo RMS B.V.
Kreuzelweg 53
5961 NM Horst
Netherlands
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 150-166 g
- Fasting period before study: Overnight
- Housing: Sighting Study: In groups of four/three during acclimatization, and two1 during the study in Makrolon type-4 cages with Lignocel S8-15 sawdust bedding.
Main Study: In groups of four/three during acclimatization and in groups of four during the study in Makrolon type-4 cages with Lignocel S8-15 sawdust bedding.
- Diet (e.g. ad libitum): Pelleted standard Teklad Global Diet 2014C rat/mouse maintenance diet ad libitum (supplied by Envigo RMS, S.A., batch nos. 021517MA and 011017MA, expiry dates: 12 November 2017 and 7 October 2017, respectively).
- Water (e.g. ad libitum): Tap water, ad libitum.
- Acclimation period: 7-14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 C
- Humidity (%): 30-70%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 June 2017 To: 26 July 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Dose formulations were prepared to administer 300 and 2000 mg/kg body weight.
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): MKBW9504V
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose levels were selected taking into account preliminary information and the results obtained from the Sighting Study.

Doses:

300, 2000 mg/kg bw

No. of animals per sex per dose:

300 mg/kg bw: 1 female
2000 mg/kg bw: 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs/mortality: Daily during the acclimatization period. Viability/mortality were checked together with clinicals signs and were recorded twice a day. Clinical signs were recorded once during the first 30 minutes after administration and at 1, 2, 3, and 5 hours folllowing administration on Day 1. Body weights were recorded on Day 1 (pre-administration), 8, and 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

During the Sighting Study, the animal dosed at 300 mg/kg did not die or show any clinical signs. Therefore, another animal was dosed at 2000 mg/kg and it showed no signs of toxicity nor did it die either. Based on this information, the test item was administered at the dose of 2000 mg/kg to four additional animals.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality due to test article administration was observed.

Clinical signs:

other: No abnormal clinical signs were observed during the study.

Gross pathology:

No abnormal macroscopic findings were noted upon gross necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the test article has a rat oral LD50 greater than 2,000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test article was evaluated in female Wistar Hannover rats. The study was conducted according to OECD 420 (2001) and was conducted in compliance with OECD GLP (1997) regulations. The test article was homogenized in corn oil and administered to 5 female rats via oral gavage at a dose volume of 10 mL/kg. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice. No mortality, abnormal clinical signs or macroscopic findings after necropsy were observed and the body weight gain shown by the animals was considered normal. Based on the results of the study, the test article has a rat oral LD50 greater than 2,000 mg/kg body weight.