Dipotassium heptafluorotantalate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19th April 2006 to 15th June 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium heptafluorotantalate

EC Number:

240-986-1

EC Name:

Dipotassium heptafluorotantalate

Cas Number:

16924-00-8

Molecular formula:

F7Ta.2K

IUPAC Name:

Tantalate(2-), heptafluoro-, potassium (1:2)

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Dikaliumheptafluorotantalat (Kaliumtantalfluorid)
- Substance type: White powder.
- Storage condition of test material: Kept tightly closed and dry at room temperature.

Test animals

Species:

rat

Strain:

other: CD(SD)IGS BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: Approximately 8 weeks old at the time of administration.
- Weight at study initiation: Mean weight of the three dose groups (g): 182.3, 194.7, 180.0 . Ranging from 173 to 201 g
- Fasting period before study: Food was taken away the evening before the test material was administered then offered 3 hours after.
- Housing: Individually in Makrolon cages type lll (39 cm x 23 cm x 18 cm). Wire mesh lids. Sanitation once weekly.
- Diet: Altomin 1324 forte ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22.1°C
- Humidity: 52.6%
- Air changes: 12 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs of artificial light/12 hrs darkness

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The test material hydrolyses in water.
- Amount of vehicle (if gavage): The exact amount was calculated based on the individual animals weight at the time of exposure.

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg body weight.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No prior information on oral toxicity was available for the test substance, therefore a starting dose of 300 mg/kg bw was chosen as a starting point.

Doses:

Dose 1: 300 mg/kg bw
Dose 2: 300 mg/kg bw
Dose 3: 2000 mg/kg bw

No. of animals per sex per dose:

3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: clinical observations were performed 0-0.5, 0.5-1, 1-2, 2-4, and 4-6 hours after administration, then once a day for 14 days.
- Frequency of observations and weighing: Body weight observations were performed before administration, 7 and 14 days post administration.
- Necropsy of survivors performed: Deceased and sacrificed animals were subjected to necropsy being dissected and examined macroscopically including gross pathological examination to identify target organs.
- Other examinations performed: clinical observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

300 - < 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No reliability limits given

Mortality:

All animals in dose group 1 and 2 (300 mg/kg body weight) survived until the scheduled termination of the study. All animals in dose group 3 died on the day of administration of the test material. An overview of mortality and clinical observations can be seen in table 2 in the field " Any other information on results incl. tables".

Clinical signs:

other: Only high dose animals were affected. The findings, with an onset shortly after the administration and lasting until death, were: Autonomous nervous effects: increased lacrimation. Central nervous effects: unconsciousness. Other effects: cyanosis. Signs o

Gross pathology:

Abnormal findings were only present in deceased animals:
Glandular stomach, mucosa and small intestine: ulcera
Stomach and small intestine: blood in the lumen.

Any other information on results incl. tables

Table 2. Results

Dose (mg/kg)	Dose No.	No. of Animals			Prominent Findings
		exposed	affected	deceased	in life	post mortem
300	1	3	0	0	none	none
300	2	3	0	0	none	none
2000	3	3	3	3	signs of reduced well-being, increased lacrimation, cyanosis, unconsciousness.	glandular stomach, mucosa and small intestine, ulcera; stomach and small intestine, blood in the lumen.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material caused gastrointestinal irritation when administered orally to rats. According to the test guidelines the LD50 was estimated to be between 300 – 500 mg/kg of body weight in rats. Therefore the test material is classified as harmful if swallowed under Directive 2001/59/EC.

Executive summary:

In a GLP compliant acute oral toxicity study conducted in accordance with OCED Guideline 423 and EU method B.1 tris, the acute oral toxicity of the substance was determined using the fixed dose procedure. Female rats were subject to an oral dose of 300 or 2000 mg/kg of the test material by oral gavage and then were observed for 14 days. No signs of ill-health were observed in animals dosed at 300 mg/kg bw; however gastrointestinal irritation was observed in animals dosed at 2000 mg/kg bw.

Under the conditions of the study, the test material was considered to be harmful if swallowed. The test material requires classification as Harmful (Xn) with the associated risk phrase R22 “Harmful if swallowed" under Directive 2001/59/EC. Under Regulation 1272/2008 the test material requires classification as "Acute Tox. 4" with the associated hazard phrase "H302: Harmful if swallowed".