Potassium trifluorozincate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Remarks:

.

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Potassium trifluorozincate

EC Number:

237-537-7

EC Name:

Potassium trifluorozincate

Cas Number:

13827-02-6

Molecular formula:

F3Zn.K

IUPAC Name:

potassium trifluorozincuide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Nocoloc Zn Flux
- Physical state: white powder
- Analytical purity: >99.00%
- Lot/batch No.: 280200
- Expiration date of the lot/batch: 27 March 2003 (1 year after receipt)
- Storage condition of test material: at room temperature in the dark

- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 6-8 weeks
- Body weight at study initiation: Males: 179-181g, Females: 134-146g (200 mg/kg bw dose group), 183-196g (2000 mg/kg bw dose group)
- Fasting period before study: feed witheld overnight (for a maximum of 20 hours) prior to dosing untill approx. 3-4 hours after administration of the test substance
- Housing: 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm) containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg, Germany)
- Diet: standard pelleted laboratory animal diet ad libitum (from Altromin (code VRF 1), Lage, Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days before the start of treatment under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accormplished to a visually accepatble level.

Doses:

Single doses of 2000 mg/kg bw (only females) or 200 mg/kg bw (males and females)

No. of animals per sex per dose:

3/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: twice daily, Body weights: Days 1 (pre-administration), 8 and 15 and at death (if found dead after day 1), Clinical signs: At periodic intervals on day 1 and once daily until day day 15.
- Necropsy of survivors performed: yes, and descriptions of all internal macroscopic abnormalities recorded.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

200 - 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Three females given 2000 mg/Kg bw were found dead within 2 hours post-treatment. No mortality occured in the 200 mg/kg bw groups.

Clinical signs:

other: None

Gross pathology:

No abnormalities

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 value of Nocoloc Zn Flux in Wistar Rats was established to be within the range of 200-2000 mg/kg body weight.

Executive summary:

In a GLP-compliant OECD Guideline 423 study with Wistar rats, the oral toxicity of Nocoloc Zn Flux was determined. Nocoloc Zn Flux was administered by oral gavage to three Wistar rats per sex per dose. Female rats were exposed to 200 and 2000 mg/kg bw and male rats to 200 mg/kg bw. Alle animal 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). Three females given 2000 mg/kg body weight were found dead. The decedents were found within 2 hours post-treatment. No further mortality occured. No clinical signs were noted. The mean body weight gain showns by the animals over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals. The oral LD50 value of Nocoloc Zn Flux in Wistar Rats was established to be within the range of 200-2000 mg/kg body weight.