Triiron bis(orthophosphate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-01-20 to 2016-02-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001-12-17

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Triiron bis(orthophosphate)

EC Number:

239-018-0

EC Name:

Triiron bis(orthophosphate)

Cas Number:

14940-41-1

Molecular formula:

Fe.2/3H3O4P or Fe3(PO4)2

IUPAC Name:

triiron bis(orthophosphate)

Test material form:

solid: particulate/powder

Details on test material:

- State of aggregation: light grey powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Germany GmbH, Sulzfeld, Germany
- Age: 8 - 12 weeks
- Weight: 205.9 to 276.7 g
- Fasting period before study: no diet overnight prior to application and 3 hours after application
- Housing: single-caged
- Diet (ad libitum, except for fasting period as described above): conventional laboratory diet (pellets, ssniff Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum): tap water (drinking quality)
- Acclimation period: at least 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw

CLASS METHOD
- Rationale for the selection of the starting dose: since there was no toxicity information on the substance to be tested available, a starting dose of 300 mg/kg bw of sample suspended in vehicle was used.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 females (3 female rats per dosing step)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were carried out after dosing at least once during the first 30 minutes, periodically during the first 24 hour, with special attention given during the first 4 hours and daily thereafter for a total of 14 days.
Individual weights of animals were determined shortly before the test substance was administered, weekly thereafter, and at the end of the test.
- Necropsy of survivors performed: yes, all test animals were subjected to gross necropsy.

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occurred.

Clinical signs:

Animals did not show any adverse clinical sings.

Body weight:

No adverse effects on body weight were recorded.

Gross pathology:

No abnormalities were detected during necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.