Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate

Acute Toxicity: dermal

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate

EC Number:

911-467-3

Molecular formula:

C2O2F3K and CO2F3KS

IUPAC Name:

Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Remarks:

aqueous solution

Test animals

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

Administration / exposure

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.

Results and discussion

Effect levels

Key result

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.

Applicant's summary and conclusion

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.

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.