Potassium trifluoroacetate

Endpoint summary

Description of key information

LD50 oral > 2000 mg/kg
LD50 dermal > 1000 mg/kg

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 26 nov 1998 to 03 nov 2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not GLP, but following the OECD guideline.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

not specified

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Nossan S.r.l, Italy
- Age at study initiation:
- Weight at study initiation: males: between 244 and 245 g; females: between 154 and 163 g
- Fasting period before study: an overnight
- Diet (e.g. ad libitum): available 4 hours after dosing
- Water (e.g. ad libitum):

IN-LIFE DATES: From 07 march 2000 to 28 march 2000

No more data available

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5%

Doses:

500 and 2000 mg/k bw

No. of animals per sex per dose:

3 females at 500 mg/kg
3 males at 2000 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs immediately upon dosing, approximately 1, 2, 4 hours after dosing and daily thereafter for a total of 14 days.
Animals were weighted on allocation to the study, prior to dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured during the study

Clinical signs:

other: 500 mg/kg: piloerection observed following dosing. Recovery within 2 days. 2000 mg/kg: piloerection an hunched posture observed following dosing. Recovery within 6 days.

Gross pathology:

No abnormalities observed.

Interpretation of results:

GHS criteria not met

Conclusions:

Potassium trifluoroacetate is not classified according to the CLP 1272/2008

Executive summary:

In a study (RTC, 2000), Sprague-Dawley rats received Potassium trifluoroacetate at doses of 500 and 2000 mg/kg in vehicle carboxymethylcellulose (CMC). The animals were observed for 14 days. No mortality was observed. Clinical signs: piloerection at 500 mg.kg (recovery within 2 days); piloerection and hunched posture at 2000 mg/kg with recovery within 6 days. The LD50 was higher than 2000 mg/kg.

In these conditions, Potassium trifluoroacetate is not harmful by ingestion, according to CLP 1272/2008/EC criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is not GLP but is following the OECD guideline.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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 22 nov 2011 to 25 jan 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

2010-12-16

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CHARLES RIVER (EUROPE) LABORATORIES INC.
- Age at study initiation: young adults
- Weight at study initiation: Between 207g and 269g
- Fasting period before study: none
- Housing: individual caging , Type II. polypropylene/polycarbonate (37*22*18 cm)
- Diet (e.g. ad libitum): ssniff® SM R/M-Z+H "Autoclavable complete feed for rats and mice – breeding and maintenance"
- Water (e.g. ad libitum): tap water from the municipal supply
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.

IN-LIFE DATES: From: 2011-11-30 To: 2011-12-14

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Shaved back
- % coverage: 10%
- Type of wrap if used: Sterile gauze pads kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was wrapped with semi occlusive plastic wrap.

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5480 mg/kg bw (2000 mg/kg bw of active ingredients)
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

5480 mg/kg bw (2000 mg/kg bw of active ingredients)

No. of animals per sex per dose:

5 animals per sex and per dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: 1 and 5 hours after application of the test item and once each day thereafter
- Weighing: Day 0 (before test item administration) and on Days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed:
- clinical signs: skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor
activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea, lethargy, sleep
and coma.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality occurred after a 24-hour dermal exposure

Clinical signs:

other: No clinical signs were observed after the treatment with the test item or during the 14 day observation period.

Gross pathology:

There was no evidence of any observations at necropsy.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal median lethal dose (LD50) of the test item Reaction mass of TFSK/TFAK was found to be higher than 2000 mg/kg bw (active ingredients) in male and female CRL:(WI)Wistar rats. It is consequently considered as not classified.

Executive summary:

An acute dermal toxicity study was performed with test item Reaction mass of TFSK/TFAK in CRL:(WI)Wistar rats, in compliance with OECD Guideline No.: 402, and under GLP conditions.

A limit test was carried out at 2000 mg/kg (active ingredients) body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period.

Clinical observations were performed on all animals at 1and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).

No mortality occurred during the study. Neither local dermal signs nor clinical signs were observed after the treatment with the test item or during the 14-day observation period. Body weight was normal and necropsy displayed no evidence of any observations at a dose level of 2000 mg/kg bw (active ingredients).

The acute dermal median lethal dose (LD50) of the test item Reaction mass of TFSK/TFAK was found to be higher than 2000 mg/kg bw (active ingredients) in male and female CRL:(WI)Wistar rats. It is consequently considered as not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is GLP and is following the OECD guideline.

Additional information

Oral:

In a study (RTC, 2000), Sprague-Dawley rats received Potassium trifluoroacetate at doses of 500 and 2000 mg/kg in vehicle carboxymethylcellulose (CMC). The animals were observed for 14 days. Clinical signs: piloerection at 500 mg/kg (recovery within 2 days); piloerection and hunched posture at 2000 mg/kg with recovery within 6 days. No mortality was observed. The LD50 was higher than 2000 mg/kg. In these conditions, Potassium trifluoroacetate is not harmful by ingestion according to the CLP 1272/2008/EC criteria.

 

Dermal:

An acute dermal toxicity study was performed with test item Reaction mass of TFSK/TFAK in CRL:(WI)Wistar rats, in compliance with OECD Guideline No.: 402, and under GLP conditions.

A limit test was carried out at 2000 mg/kg (active ingredients) body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14‑day observation period. Clinical observations were performed on all animals at 1and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).

No mortality occurred during the study. Neither local dermal signs nor clinical signs were observed after the treatment with the test item or during the 14-day observation period. Body weight was normal and necropsy displayed no evidence of any observations at a dose level of 2000 mg/kg bw (active ingredients).

The acute dermal median lethal dose (LD50) of the test item Reaction mass of TFSK/TFAK was found to be higher than 2000 mg/kg bw (active ingredients) in male and female CRL:(WI)Wistar rats.

In this study, about 50 % (49.3 %) of the active ingredients is TFAK, the remaining being TFSK. Therefore, actual TFAK LD50 > 1000 mg/kg bw. However, considering that no clinical signs were observed in this study, dermal absorption is expected to be lower than gastrointestinal absorption and because no death was observed in the TFAK oral acute toxicity study, we expect that TFAK LD50 is well over 2000 mg/kg.

TFAK is consequently considered as not classified for acute dermal toxicity.

 

Inhalation:

No study was available. As there were data on oral and dermal route, data on inhalation route is not required, because it is not the main route of exposure. Considering the very low vapor pressure of TFAK and the absence of toxicity obsrved in dermal and oral acute toxicity studies. No toxicity is expected by the inhalation route. 

Justification for classification or non-classification

Based on results observed by oral and dermal route, no classification is required for potassium trifluoroacetate according to the CLP 1272/2008 regulation criteria.