Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
FROM 3 JULY 2013 to 27 SEPTEMBER 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
up-and-down procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-difluoroethyl acetate
EC Number:
801-773-4
Cas Number:
1550-44-3
Molecular formula:
C4H6F2O2
IUPAC Name:
2,2-difluoroethyl acetate
Test material form:
liquid
Remarks:
clear and colorless.

Test animals

Species:
rat
Strain:
other: Crl:CD(SD) rats
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10-11 weeks old on the day of dosing.
- Weight at study initiation: 209.7 to 228.8 grams.
- Fasting period before study: the rats were fasted approximately 16-17.25 hours prior to dosing with food being returned to the rats approximately 2.75-3 hours after dosing.
- Housing: animals were housed individually in solid-bottom caging with bedding and appropriate species specific enrichment.
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 ad libitum.
- Water: ad libitum.
- Acclimation period: the rats were weighed and observed for general health during a 6-day quarantine period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26ºC.
- Humidity (%): 30-70%.
- Photoperiod: animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.

IN-LIFE DATES: From 9 JULY 2013 to 21 AUGUST 2013.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
The rats were dosed with the neat, undiluted test substance. Individual dose volumes were calculated using the test substance density of 1202.5 mg/mL and the fasted body weights obtained prior to dosing.
Details on oral exposure:
The neat test material was administered by oral gavage to the four fasted females.
Doses:
5000 mg/kg bw.
No. of animals per sex per dose:
A single dose of the test material was administered to 4 female rats at 5000 mg/kg.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: observations for mortality and signs of illness, injury or abnormal behavior were made daily throughout the study. The rats were observed for clinical signs at the beginning of fasting, just before dosing (test day 1), once during the first 30 minutes after dosing and 2 more times on the day of dosing, and once each day thereafter.
- Frequency of weighing: the rats were weighed on test days -1, 1, 8, 15, and on the day of sacrifice.
- Necropsy of survivors performed: yes. On test day 15, the rats were euthanized and necropsied to detect grossly observable evidence of organ or tissue damage. One animal was sacrificed and necropsied on test day 4 for humane reasons. The rats were euthanized by exsanguination while under isoflurane anesthesia.
Statistics:
A software package (AOT425StatPgm) was used to determine the dose progression and to estimate the LD50.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Three out of the 4 animals survived to scheduled sacrifice. One animal was sacrificed on test day 4 for humane reasons.
Clinical signs:
other: See below:
Body weight:
other body weight observations
Remarks:
The animal that was sacrificed on test day 4 exhibited body weight loss of 17%. No other animals exhibited body weight loss over any of the measured intervals.
Gross pathology:
Gross findings were present in the one female rat that was sacrificed on test day 4. These included kidney, spleen, and stomach discoloration, as well as red fluid in the urinary bladder. No gross findings were observed in the animals that survived to scheduled sacrifice.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the oral LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg in female rats.
Executive summary:

The acute oral toxicity of 2,2-Difluoroethyl acetate was investigated in a study performed according to OECD test guideline 425 (Up-and-Down Procedure) under GLP compliance.


A single dose of 5000 mg/kg bwt was administered neat by gavage to four fasted female Crl:CD(SD) rats. The rats were dosed one at a time at a minimum of 48-h intervals. The observation period lasted 14 days following administration. All rats were observed for mortality, body weight effects, and clinical signs. On day 15, the rats were necropsied to detect grossly observable evidence of organ or tissue damage.


Three out of the four animals survived to scheduled sacrifice. One animal was sacrificed on test day 4 for humane reasons. All four animals exhibited ataxia and low posture. One or more animals also exhibited fast breathing, coldness to touch, moribund status, decreased muscle tone, high posture, prostration, or slow/absent righting reflex. Among the three animals that survived to scheduled sacrifice, all clinical signs abated by day 5. The animal that was sacrificed on day 4 exhibited body weight loss of 17%. No other animals exhibited body weight loss over any of the measured intervals. Gross findings were present in the one female rat that was sacrificed on day 4. These included kidney, spleen, and stomach discoloration, as well as red fluid in the urinary bladder. No gross findings were observed in the animals that survived to scheduled sacrifice.


Under the conditions of this study, the acute oral LD50 value of 2,2-Difluoroethyl acetate was determined to be greater than 5000 mg/kg bwt in female rats.