1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

Remarks:

No deviations ocurred that would have impacted the integrity of the results of the study.

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

EC Number:

817-766-4

Cas Number:

91891-42-8

Molecular formula:

C6F12O

IUPAC Name:

1,1,2,3,3-pentafluoro-3-(heptafluoropropoxy)prop-1-ene

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company
- Expiration date of the lot/batch: No data
- Purity test date: 05 Feb, 2018

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity, protected from light and stored under enert gas
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING : None, dosed unchanged

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 4-5 weeks
- Weight at study initiation: 174-216 grams
- Fasting period before study: 16-20 hours prior to dosing
- Housing: The animals were individually housed in suspended wire-bottom cages.
- Diet (e.g. ad libitum): resh PMI Rat Chow (Diet No.5012) was available ad libitum except for 16-20 hours prior to dosing.
- Water (e.g. ad libitum): Water was available ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): "Temperature controlled"
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 July 2018 To: 22 August 2018

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: None

MAXIMUM DOSE VOLUME APPLIED: No data

Doses:

175, 550, 2000 mg/kg body weight

No. of animals per sex per dose:

175 mg/kg (1 female), 550 mg/kg (1 female), 2000 mg/kg (3 females)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Body weights were recorded pre-test, weekly, and at termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology upon necropsy

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: 175 mg/kg: No abnormal clinical signs were noted. 550 mg/kg: Piloerection was observed. 2000 mg/kg: Abnormal physical signs including diarrhea, partially chewed food, wet anogenital area, piloerection, diminished fecal output, chromorhinorrhea, nose/mouth

Gross pathology:

No abnormal gross pathological findings were noted upon necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

The acute oral lethality potential of the test article was evaluated in female Sprague Dawley rats. The study was conducted according to OECD 425 in compliance with OECD GLP regulations. A single female rat was dosed via oral gavage with 175 mg/kg body weight of the test article. Since the rat survived, an additional female was dosed with 550 mg/kg. As those rats both survived, a group of three female rats were dosed with 2,000 mg/kg. Animals were observed at 15 minutes, 1, 2 and 4 hours post-dosing and once daily thereafter for 14 days for toxicity and pharmacological effects. Body weights were recorded pre-test, weekly, and at termination. No mortality occurred during the study. Piloerection was observed in the 550 mg/kg rat and diarrhea, partially chewed food, wet anogenital area, piloerection, diminished fecal output, chromorhinorrhea, nose/mouth area stained red and thinning hair on the right and left hind limbs were observed in the rats dosed with 2,000 mg/kg. Based on the results of the study, the oral LD50 of the test article is greater than 2,000 mg/kg body weight.