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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Remarks:

No deviations occurred that impacted the integrity of the study.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

252-044-7

EC Name:

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

Cas Number:

34455-00-0

Molecular formula:

C8H10F9NO4S

IUPAC Name:

1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulfonamide

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company, Lot 38015
- Expiration date of the lot/batch: April 20, 2018
- Purity test date: April 20, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: reported as "Room temperature and humidity"

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was individually weighed and moistened with distilled water to form a paste consistency.

FORM AS APPLIED IN THE TEST: Moistened with water to form a paste.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Stone RIdge, NY
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks
- Weight at study initiation: Male range: 263-282 g, Female range: 208-229 g
- Fasting period before study: None
- Housing: Individually in suspended wire-bottom cages.
- Diet (e.g. ad libitum): PMI Rat Chow (Diet No. 5012) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data in final report but it did not deviate from the guideline-specified temperature range.
- Humidity (%): No data in final report but it did not deviate from the guideline-specified humidity range.
- Air changes (per hr): No data in final report but it did not deviate from the guideline-specified air change range.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 May, 2017 To: 15 June, 2017

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: The test article was moistened with distilled water to create a paste.

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal
- % coverage: 10% of body surface
- Type of wrap if used: Porous dressing and porous non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Distilled water
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for mortality, toxicity and clinical signs were recorded at one and four hours postdosing and once daily thereafter for 14 days. Body weights were recorded pre-test, weekly and at termination.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Immediately following unwrapping, erythema was absent to very slight and edema was absent. By Day 14, erythema edema were absent.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Chromorhinorrhea and wetness of the anogenital area were observed.

Gross pathology:

No abnormalities were observed upon necrospy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the dermal LD50 of the test article is greater than 2,000 mg/kg body weight.

Executive summary:

The dermal lethality potential of the test article was evaluated in male and female Sprague Dawley rats. The study was performed in compliance with OECD GLP regulations. The test was performed according to OECD 402. Rats (5 males and 5 females) received a 24-hour dermal exposure of 2000 mg/kg. The test article was moistened with distilled water on porous gauze and applied to the dorsal region (clipped, 10% body surface) of each rat. The exposure site was wrapped with porous dressing and porous non-irritating tape (semi-occlusive). After 24 hours the gauze was removed and any remaining test article was removed by washing with distilled water. All rats survived the study. Clinical observations included chromorhinorrhea and wetness of the anogenital area. Immediately following unwrapping, erythema was absent to very slight and edema was absent. By Day 14, erythema and edema were absent. Based on the results of the study, the rat dermal LD50 of the test article is greater than 2,000 mg/kg body weight.