Registration Dossier
Registration Dossier
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EC number: 911-467-3 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 Jul 2018 to 20 Feb 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2019-02-11
- Test type:
- acute toxic class method
Test material
- 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
- 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
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Beijing Vital River Laboratory Animal Technology Co., Ltd
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 57-72 days
- Weight at study initiation: 205-245 g
- Housing: Suspended, stainless steel cages (L32xW28xH20 cm); housed individually
- Diet (e.g. ad libitum): SPF Rodent Maintenance Feed (Beijing Keaoxieli Feed Co., Ltd), ad libitum (except fasting overnight before dosing and 3-4h after)
- Water (e.g. ad libitum): Purified water, ad libitum
- Acclimation period: 6 days
- Method of randomisation in assigning animals to test and control groups: use of Excel's random function
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 24.9 °C
- Humidity (%): 45-72%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- CLASS METHOD
- Rationale for the selection of the starting dose: Based on previously available information. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Once to twice daily for mortality; clinical observations were performed 30min, 1, 2 and 4h after applications and then once daily; body weights were determinde on days 0, 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- Not applicable
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality observed
- Clinical signs:
- other: No abnormalities at all clinical symptom observations after dosing.
- Gross pathology:
- No abnormalities observed at necropsy.
Any other information on results incl. tables
Deviations from protocol: Six times points of humidity deviated with the highest value measured being 72%. Deviations were very short time periods. This does not affect the quality and integrity of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Reaction mass of TFSK/TFAK was found to be above 2000 mg/kg bw.
- Executive summary:
An assessment of the acute oral toxicity of TFSK TFAK Reaction mass to rats was realized according to the OECD 423 guideline (Acute Toxic Class Method) and under GLP conditions. Initially, TFSK TFAK Reaction mass was administered by oral gavage to three female Sprague Dawley rats at 2000 mg/kg body weight. In a stepwise procedure one additional group of three females was dosed at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15).
At 2000 mg/kg, no mortality occurred (0/6 rats). There were no abnormalities observed for clinical signs or at necropsy. Body weight gain was observed in all rats. The oral LD50 value of TFSK TFAK Reaction mass in Sprague Dawley rats was established to be > 2000 mg/kg body weight.
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