1,1,1,3,3,3-hexafluoro-2-methoxypropane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 August 2017 thru 6 September 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:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

1998

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1,1,3,3,3-hexafluoro-2-methoxypropane

Cas Number:

13171-18-1

Molecular formula:

C4-H4-F6-O

IUPAC Name:

1,1,1,3,3,3-hexafluoro-2-methoxypropane

Test material form:

liquid: volatile

Specific details on test material used for the study:

CASNo.: 13171-18-1
Lot #: HFMOP17004
Storage: Room Temp.
Purity: >99.99%
Description: Clear Liquid
pH: Neutral molecule
Stability: Expected to be stable for the duration of testing.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAGE Labs on August 16, 2017
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks (young adults)
- Weight at study initiation: males 261 - 280 grams; females 173-205 grams
- Fasting period before study:Yes
- Housing: Stainless steel cages with enrichment (e.g. toy) and litter paper beneath the cage changed at least 3 times per week.
- Diet (e.g. ad libitum): Envigo Teklad Global 16% Protein Rodent Diet #2016 ad libitum.
- Water (e.g. ad libitum): Filtered tap water ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 45 - 60
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal
- % coverage: 10%
- Type of wrap if used: gauze pad and Durapore tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with 3% soap solution followed by tap water rinse and wiped with clean paper towel.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg-bw
- Concentration (if solution): 100%
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable.

VEHICLE: None

Duration of exposure:

24 hours

Doses:

5000 mg/kg-bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the first several hours and at least once daily thereafter. Weights taken prior to dosing and on days 7 and 14.
- Necropsy of survivors performed: yes. Gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Cage-side observations for mortality, signs of gross toxicity, behavior changes; including gross evaluation of skin and fur, eyes and mucous membranes, repiratory, circulatory, autonomic and central nervious systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, and coma.

Statistics:

Limited to calculation of the mean density value for dosing.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

None.

Clinical signs:

other: None. All animals were healthy and active throughout the study.

Gross pathology:

No gross abnormalities observed.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is non-toxic in rats up at a limit dose of 5000 mg/kg. Therefore, the Dermal LD50 is >5000 mg/kg-bw.

Executive summary:

In a GLP guideline study conducted according to US EPA OPPTS 870.1200 (1998) to assess the acute dermal toxicity with 5 male and 5 female Sprague-Dawley young adult rats, no mortalities were observed at the limit dose of 5000 mg/kg-bw. All animals were healthy and active throughout the study and 14 -day observation period and there were no gross abnormalities observed at necropsy. Therefore, the Dermal LD50 is >5000 mg/kg-bw.