Iron tris(phosphinate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from secondary source

Data source

Reference

Reference Type:

secondary source

Title:

Acute oral toxicity study of test chemical was performed in rodents.

Author:

European Food Safety Authority (EFSA)

Year:

2013

Bibliographic source:

Renewal Assessment Report of Ferric phosphate

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

Acute Oral toxicity test was carried out to study the effects of test chemical on rats.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Iron orthophosphate

EC Number:

233-149-7

EC Name:

Iron orthophosphate

Cas Number:

10045-86-0

Molecular formula:

Fe.H3O4P

IUPAC Name:

Ferric phosphate

Details on test material:

- Name of test material (IUPAC name): ferric orthophosphate
- Common name: Ferric phosphate
- Molecular formula :Fe.H3O4P
- Molecular weight :150.815 g/mol
- Smiles notation: P(=O)([O-])([O-])[O-].[Fe+3]
- InChl: 1S/Fe.H3O4P/c;1-5(2,3)4/h;(H3,1,2,3,4)/q+3;/p-3
- Substance type:inorganic
- Physical state:Yellowish powder
- Purity :Minimum 24.8 % Fe

Test animals

Species:

rat

Strain:

other: Wistar Crl: (Wi) BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Source:Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: Approximately 8 weeks old at time of dosing
- Weight at study initiation: Males: 268-310 g
Females: 194-205 g
- Housing: Groups of three by sex in polycarbonate cages with sawdust bedding
- Diet (e.g. ad libitum): Standard pelleted laboratory diet supplied by Carfill Quality BVBA,Belgium ad libitum
- Water (e.g. ad libitum): Ad libitum access to tap water.
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%):55 ± 15 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): Alternating 12 hour light/dark cycle

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

propylene glycol

Details on oral exposure:

no data available

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total: 6 animals
5000 mg/kg bw:3 males and 3 females

Control animals:

not specified

Details on study design:

Details on study design:
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights

Statistics:

no data available

Results and discussion

Preliminary study:

no data available

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at dose 5000 mg/kg bw in treated rats

Clinical signs:

other: Clinical signs of systemic toxicity or reaction to treatment included lethargy, uncoordinated movements and staining of the eye on day 1.

Gross pathology:

No macroscopic abnormalities were noted during necropsy.

Other findings:

no data available

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw,when male and female wistar rats were treated with test chemical orally according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Executive summary:

Acute oral toxicity study was performed in male and female wistar rats using test chemical according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).No mortality was observed at dose 5000 mg/kg bw.Clinical signs of systemic toxicity or reaction to treatment included lethargy, uncoordinated movements and staining of the eye on day 1.No effects on body weight or weight gain were recorded. No macroscopic abnormalities were noted during necropsy.Hence,LD50 value was considered to be >5000 mg/kg bw,when wistar rats were treated with test chemical orally.