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Administrative data

Description of key information

Acute oral toxicity: The LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg bw in female rats.


Acute inhalation toxicity: The LC50 of 2,2-Difluoroethyl acetate was greater than 5600 ppm (i.e. greater than 28 mg/L) in male and female rats.


Acute dermal toxicity: The LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg bw in male and female rats.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
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
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.
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.
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw
Quality of whole database:
A GPL-compliant study performed according to OECD test guideline 425 (Up-and-Down Procedure) is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 JUNE 2013 to 11 NOVEMBER 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
2009
Deviations:
yes
Remarks:
Some temperature and relative humidity deviations occurred but they did not adversely affect the results or interpretation of this study.
GLP compliance:
yes (incl. QA statement)
Test type:
traditional method
Limit test:
no
Species:
rat
Strain:
other: Crl:CD(SD) rats
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: male and female rats were obtained from Charles River Laboratories International, Inc., Raleigh, North Carolina.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: approximately 8 weeks old.
- Weight at study initiation: male rats weighed between 250 and 292 grams and female rats weighed between 185 and 221 grams at the time of exposure. The weight variation in animals used on an exposure did not exceed ± 20% of the mean weight of each sex.
- Fasting period before study: none.
- Housing: except during exposure, animals were housed individually in solid bottom caging with Enrich-O-Cob for bedding and enrichment.
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 ad libitum except during exposure.
- Water: tap water ad libitum except during exposure.
- Acclimation period: 6-day quarantine. During this period, animals were weighed and observed for clinical signs of disease. Animals that were released from quarantine, had been gaining weight at a normal rate and had no overt signs of disease.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 25°C. The chamber temperatures were briefly 1.0ºC higher than the upper target range during the 350 ppm exposure. The chamber temperature was within the animal room temperature specifications.
- Humidity (%): 58 - 99%. The humidity exceeded the upper limit in all exposures however the high humidity did not persist throughout the entire exposures.
The chamber temperature and relative humidity deviations did not adversely affect the results or interpretation of this study.
- Air changes (per hr): 10 L/minute, which produced approximately 32 air changes per hour. The chamber oxygen concentrations ranged from 20.6 to 20.9%.
- Photoperiod: animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.

IN-LIFE DATES: From 8 July 2013 to 14 August 2013.
Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus and exposure chamber volume: The exposure chamber was constructed of glass (cylindrical) with a nominal internal volume of 19L.
- Method of holding animals in test chamber: Before the exposures, animals were placed in stainless steel, wire-mesh modules (sexes separate) and then exposed, whole-body, inside the 19-L glass exposure chamber. The modules were placed on a stainless steel stand inside the exposure chamber so that the animals were elevated from the bottom of the exposure chamber.
- Air generation: Houseline generation (and chamber supply) air, was metered to the round-bottom flask with a Brooks model 5850E mass flow controller and carried the vapor and air mixture into a glass transfer tube that led to the exposure chamber.
- Treatment of exhaust air: The test atmosphere was exhausted through a dry-ice cold trap followed by an MSA charcoal/HEPA filter cartridge prior to discharge into the fume hood.

TEST ATMOSPHERE
- Brief description of method and equipment used: Chamber atmospheres were generated by flash evaporation of H-30299 in air. The test substance was metered into a heated round-bottom, flash evaporation flask with a Harvard Apparatus model 22 Syringe Infusion Pump. The round-bottom flask was heated to 175°C to vaporize the test substance. Houseline generation (and chamber supply) air, was metered to the round-bottom flask with a Brooks model 5850E mass flow controller and carried the vapor and air mixture into a glass transfer tube that led to the exposure chamber. Chamber concentrations of the test substance were controlled by varying the test substance feed rate to the round-bottom flask. The infusion pump and the heating mantle were monitored and controlled by the Camile Inhalation Toxicology Automated Data System (CITADS).
- Samples taken from breathing zone: yes. Prior to the start of the exposure phase, the distribution of the test substance atmosphere within the exposure chamber was determined to ensure an even atmosphere delivery to the animals. Chamber samples were collected from 2 separate locations in the exposure chamber and at the chamber reference port.
- Time needed for equilibrium of exposure concentration before animal exposure: Approximately 20 minutes are needed to reach equilibrium.

VEHICLE
None used.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Using Gas Chromatography with Flame Ionization Detection (GC-IFD). For further details, see in the field "Any other information on materials and methods incl. tables".
Duration of exposure:
4 h
Remarks on duration:
Animals were exposed to the test substance during both the time it took for the chamber to reach concentration (approximately 20 min) and the time it took for the test substance to be purged from the chamber.
Concentrations:
The tested concentrations were 350 ± 31, 1500 ± 310 and 5600 ± 820 ppm (equivalent to 1.77 ± 0.16, 7.60 ± 1.57, 28.36 ± 4.15 mg/L*, respectively).

* Conversion from ppm to mg/L:
Test concentrations (mg/m3) = Test concentrations (ppm) x Molecular weight (g/mol) / 24.5 (L/mol)
Where:
Test concentrations (ppm) = 350 ± 31 or 1500 ± 310 or 5600 ± 820
Molecular weight (g/mol) = 124.09
24.5 L/mol = gas constant at 25 °C and 1013.25 hPa
Test concentrations (mg/m3) = [350 ± 31 or 1500 ± 310 or 5600 ± 820] x 124.09 / 24.5
Test concentrations (mg/m3) = 1773 ± 157 or 7597 ± 1570 or 28363 ± 4153
Test concentrations (mg/L) = 1.77 ± 0.16 or 7.60 ± 1.57 or 28.36 ± 4.15
No. of animals per sex per dose:
5 males and 5 females per dose group.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: animals were observed for mortality and response to alerting stimuli during exposure and immediately after they were removed from the exposure chamber. During the 14-day recovery period, all rats were observed each day for mortality and were weighed and observed for clinical signs of toxicity.
- Necropsy of survivors performed: on the last day of the recovery period, all rats were sacrificed by isoflurane anesthesia, exsanguinated, and necropsied. All animals were given a complete gross pathology examination of their internal organs including observation of the nasal passages.
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5 600 ppm
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: equivalent to > 28 mg/L
Mortality:
All animals survived the exposures and subsequent 14-day recovery period.
Clinical signs:
other: See in the field "Any other information on results incl. tables".
Body weight:
In general, the severity and duration of body weight losses observed during the recovery periods were concentration related:
1) 350 ppm: on the day after the exposure, 7 of 10 rats lost between 1.1 and 4.8% of their initial body weight followed by normal weight gain throughout the remainder of the recovery period.
2) 1500 ppm : nine of 10 rats lost between 0.71 and 13% of their initial body weight on the day following the exposure. Minor weight losses ranging from 0.19 to 2.6% were observed in some rats from test day 3 until test day 7, followed by normal weight gain throughout the second week of the recovery period.
3) 5600 ppm: all rats lost between 8.4 and 15% of their initial body weight on the day after the exposure. Weight losses from 0.74 to 6.1% were observed in half of the rats on post-exposure day 2, followed by normal weight gain throughout the remainder of the recovery period.
Gross pathology:
No gross lesions were observed in any rats at necropsy.

Chamber Distribution of Vapor:


 


Chamber samples were collected from 2 separate locations in the exposure chamber and at the chamber reference port. Indeed the male rats were placed near the bottom of the chamber, and the female rats were placed above them near the middle of the chamber during exposures; therefore the samples for determination of chamber homogeneity were collected from these 2 locations. The samples were averaged, and the individual samples were compared to the overall average. All samples taken from where the animals were exposed were less than 1.1% different from the overall mean value determined; therefore, the vapor atmosphere was considered homogeneously distributed and the use of the reference port for air sampling was considered adequate.


 


Mean exposure concentrations:


 


The mean chamber test material vapor concentrations were 350 ± 31, 1500 ± 310 and 5600 ± 820 ppm for the exposures, see Table 1 below. The chamber atmospheres were considered adequate for inhalation testing in rats.


 


Table 1: Chamber concentrations of test material















































 



ppm



mg/L



n



Mean



S.D.



Range



Mean



S.D.



Range



16



350



31



290 – 400



1.8



0.16



1.4 – 2.0



16



1500



310



1000 – 1900



7.6



1.6



5.3 – 9.6



16



5600



820



4100 - 6600



28



4.2



21 - 33



N: number of samples


S.D. standard Deviation


 


Clinical Observations:


 


During exposure:


All rats displayed normal alerting response during all 3 exposures. 


There were no clinical signs of toxicity observed in any rats in the 350 ppm exposure group during the exposure. 


Rats in the 1500 exposure group displayed decreased activity throughout the exposures.


Rats in the 5600 ppm exposure group displayed decreased activity throughout the exposures. In addition, rats in this group displayed labored breathing and/or gasping during the exposure.


 


Post exposure:


There were no clinical signs of toxicity observed in any rats in the 350 ppm exposure throughout the recovery period. 


On the first day of the two-week recovery period, one male rat in the 1500 ppm exposure group displayed lethargy, hunched posture, and had a red stained head. There were no other biologically significant clinical signs of toxicity observed in any rats in the 1500 ppm exposure group throughout the 14-day recovery period.


Clinical signs of toxicity observed in all rats after the 5600 ppm exposure were ataxia, labored breathing, and lethargy; other clinical signs observed in some of the 5600 ppm rats after the exposure included hunched posture, clear discharge from the mouth and red stained fur on the face or head. On the day following the 5600 ppm exposure, clinical signs observed in 5 of 10 rats included hunched posture, lethargy, labored breathing, and red stained fur on the face or head. There were no abnormal clinical signs of toxicity observed in any rats from the 5600 ppm group from post-exposure day 2 throughout the remainder of the recovery period.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the 4-hour LC50 of 2,2-Difluoroethyl acetate (administered as vapor) was greater than 5600 ppm (i.e. greater than 28 mg/L) in male and female rats.
Executive summary:

The acute inhalation toxicity of 2,2-Difluoroethyl acetate was investigated in a study performed according to OECD test guideline 403 under GLP compliance.


Three groups of five male and five female Crl:CD(SD) albino rats were exposed whole-body for a single 4-hour exposure to three concentrations of 350 ± 31, 1500 ± 310 and 5600 ± 820 ppm (equivalent to 1.77 ± 0.16, 7.60 ± 1.57, 28.36 ± 4.15 mg/L, respectively). 2,2-Difluoroethyl acetate was generated as a vapour. During a 14-day recovery period, all animals were weighed and observed for mortality and clinical signs of toxicity. A gross pathological examination was performed on all animals at the scheduled necropsy.


There were no deaths during this study.


There were no clinical signs of toxicity observed in any rats in the 350 ppm exposure group during the exposure or the recovery period. All rats displayed normal alerting response during exposure to the three concentrations; however, rats in the 1500 and 5600 ppm exposure group displayed decreased activity throughout the exposure. In addition, rats in the 5600 ppm exposure group displayed labored breathing and/or gasping during the exposure. On the first day of the two-week recovery period, one male rat in the 1500 ppm exposure group displayed lethargy, hunched posture, and had a red stained head. There were no other biologically significant clinical signs of toxicity observed in any rats in the 1500 ppm exposure group throughout the 14-day recovery period. Clinical signs of toxicity observed in all rats after the 5600 ppm exposure were ataxia, labored breathing, and lethargy; other clinical signs observed in some of the 5600 ppm rats after the exposure included hunched posture, clear discharge from the mouth and red stained fur on the face or head. On the day following the 5600 ppm exposure, clinical signs observed in 5 of 10 rats included hunched posture, lethargy, labored breathing, and red stained fur on the face or head. There were no abnormal clinical signs of toxicity observed in any rats from the 5600 ppm group from post-exposure day 2 throughout the remainder of the recovery period.


On the day after the exposure, 7 of 10 rats in the 350 ppm exposure group lost between 1.1 and 4.8% of their initial body weight followed by normal weight gain throughout the remainder of the recovery period. Nine of 10 rats in the 1500 ppm exposure group lost between 0.71 and 13% of their initial body weight on the day following the exposure. Minor weight losses ranging from 0.19 to 2.6% were observed in some rats in the 1500 ppm group from test day 3 until test day 7, followed by normal weight gain throughout the second week of the recovery period. All rats in the 5600 ppm group lost between 8.4 and 15% of their initial body weight on the day after the exposure. Weight losses from 0.74 to 6.1% were observed in half of the 5600 ppm rats on post-exposure day 2, followed by normal weight gain throughout the remainder of the recovery period.


There were no gross lesions observed in any rats in this study.


Under the conditions of this study, the acute inhalation 4-hour LC50 value of 2,2-Difluoroethyl acetate was determined to be greater than 5600 ppm (equivalent to greated than 28.36 mg/L) in male and female rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
> 28 mg/L air
Physical form:
inhalation: vapour
Quality of whole database:
A GPL-compliant study performed according to OECD test guideline 403 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data.

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
FROM 31 AUGUST 2015 TO 21 NOVEMBER 2015.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987.
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories International, Inc., Raleigh, North Carolina, U.S.A.
- Females nulliparous and non-pregnant: yes.
- Age at study initiation: the animals were approximately 9 weeks old on the day of dosing.
- Weight at study initiation: female weight was in the range 211.2 - 228.3 g and male weight was in the range 318.4 - 346.7 g.
- Fasting period before study: no.
- Housing: animals were housed individually in solid-bottom caging with bedding and appropriate species specific enrichment.
- Diet: the rats were fed PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 ad libitum.
- Water: all rats were provided tap water ad libitum.
- Acclimation period: the rats were weighed and observed for general health during the 7-day quarantine period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C.
- Humidity (%): 30-70%.
- Photoperiod: animal rooms were artificially illuminated (fluorescent light) on an approximate12-hour light/dark cycle.

IN-LIFE DATES: From: 10 September 2015 To: 24 September 2015.
Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: approximately 5 cm x 7.4 cm.
- Preparation of animals for exposure and application conditions: approximately 24 hours before dosing, the fur of each rat was closely shaved to expose the back from the scapular to the lumbar region. The test substance was inverted to mix before the dosing procedure. An aliquot of test substance was spread evenly, directly on the skin, covering an area of approximately 37 square centimetres. The rats were reshaved as needed during the study.
- % coverage: approximately 10% of the total body surface.
- Type of wrap if used: the test material was covered with a 2-ply gauze patch. The rats were then wrapped with stretch gauze bandage and self-adhesive bandage. .

REMOVAL OF TEST SUBSTANCE
- Washing and time after start of exposure: approximately 24 hours after treatment, the
wrappings were removed. Excess test material was washed from the dorsal skin of each rat with paper towels soaked in warm water, and the skin was dried.

TEST MATERIAL
- Amount(s) applied and concentration: the amount of neat test material designated for each animal was calculated based on body weights collected prior to treatment and the test material density of 1210 mg/mL, to obtain a dose level of 5000 mg/kg bw.
Duration of exposure:
24 hrs.
Doses:
5000 mg/kg bw (males and females).
No. of animals per sex per dose:
5 males and 5 females.
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: the rats were observed for clinical signs prior to and after dosing, immediately after wrapping removal/washing and then daily. Daily animal health observations were conducted throughout the study for mortality and signs of illness, injury, abnormal behavior. The rats were weighed on test days 1, 8, and 15.
- Necropsy of survivors performed: yes. All rats were euthanized at the end of the 15-day test period by exsanguination while under isoflurane anesthesia and examined to detect grossly observable evidence of organ or tissue damage.
- Other examinations performed: Dermal effects were scored according to the Draize Scale immediately after wrapping removal/washing. The rats were observed daily for dermal irritation (weekends and holidays excluded).
Statistics:
Not relevant for that study.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no instances of mortality.
Clinical signs:
salivation
Body weight:
other body weight observations
Remarks:
There were no overall (test day 1-15) body weight losses among any animals.
Gross pathology:
No gross lesions were present in the rats at necropsy.
Other findings:
Skin responses:
At the beginning of the observation period (approximately 24 hours after exposure), on test day 2, erythema (with a score of 1) was observed in one male, which was resolved by test day 3. There were no instances of edema observed. A scab on the back was observed in one male between test days 4-6 and in one female between test days 4-5.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the dermal LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg in male and female rats.
Executive summary:

The acute dermal toxicity of 2,2-Difluoroethyl acetate was investigated in a study performed according to OECD test guideline 402 under GLP compliance.


A single dose of 5000 mg/kg bwt was applied neat to the shaved, intact skin of five male and five female Crl:CD(SD) rats. The application site was covered with a semi-occlusive dressing for 24 h, after which the test substance was removed. The observation period lasted 14 days following application. All rats were observed for mortality, body weight effects, clinical signs and dermal response (according to the Draize scale, Draize et al. 1944). On day 15, the rats were necropsied to detect grossly observable evidence of organ or tissue damage.


There were no instances of mortality. A scab on the back was observed in one male, between days 4-6 and in one female, between days 4-5. Salivation was observed in one male on day 1 during the exposure period, which was likely a reaction to the wrapping procedure. No other clinical abnormalities were observed. At the beginning of the observation period (approximately 24 h after exposure), on day 2, erythema (with a score of 1) was observed in one male, which was resolved by day 3. There were no instances of edema observed. There were no overall (days 1-15) body weight losses among any animals. No gross lesions were present in the rats at necropsy.


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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
> 5 000 mg/kg bw
Quality of whole database:
A GPL-compliant study performed according to OECD test guideline 402 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data.

Additional information

Justification for classification or non-classification

Acute Oral Toxicity: in accordance with criteria of the CLP Regulation, 2,2-Difluoroethyl acetate does not need to be classified for acute oral toxicity (LD50 > 5000 mg/kg bw).


Acute Inhalation Toxicity: in accordance with criteria of the CLP Regulation, 2,2-Difluoroethyl acetate does not need to be classified for acute inhalation toxicity (LC50 > 5600 ppm i.e. > 28 mg/L).


Acute Dermal Toxicity: in accordance with criteria of the CLP Regulation, 2,2-Difluoroethyl acetate does not need to be classified for acute dermal toxicity (LD50 > 5000 mg/kg bw).