Iron tris(phosphinate)

Endpoint summary

Description of key information

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Ferric hypophosphite (7783-84-8).The studies are as mentioned below:

1.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.

2.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 3850 mg/kg bw. Hence,LD50 value was considered to be 3850 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies,Ferric hypophosphite (7783-84-8)and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ferric hypophosphite (7783-84-8) cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical Ferric hypophosphite (7783-84-8)is not likely to be toxic atleast in the dose range of 3850->5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

experimental data of read across substances

Justification for type of information:

Data for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

WoE report is based on two acute oral toxicity studies as-
1.and 2. Acute Oral toxicity test was carried out to study the effects of the test chemicals on rodents

GLP compliance:

not specified

Test type:

other: 1.acute toxic class method 2.no data available

Limit test:

no

Specific details on test material used for the study:

- Name of test material: Ferric hypophosphite
- IUPAC name: iron(3+) ion triphosphinate
- Molecular formula: FeO6P3
- Molecular weight: 250.8084 g/mole
- Smiles : [Fe+3].[O-]P=O.[O-]P=O.[O-]P=O
- Inchl: 1S/Fe.3H3O2P/c;3*1-3-2/h;3*3H2,(H,1,2)/q+3;;;/p-3
- Substance type: Inorganic
- Physical state: Solid powder (white to grey)

Species:

rat

Strain:

other: 1.Wistar Crl: (Wi) BR 2.not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

1.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



2.not specified

Route of administration:

oral: unspecified

Vehicle:

other: propylene glycol

Details on oral exposure:

no data available

Doses:

1.5000 mg/kg bw
2.3850 mg/kg bw

No. of animals per sex per dose:

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

2.not specified

Control animals:

not specified

Details on study design:

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

2.not specified

Statistics:

no data available

Preliminary study:

no data available

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 850 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50% mortality was observed

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:

1.No mortality was observed at dose 5000 mg/kg bw in treated rats
2.50% mortality was observed at dose 3850 mg/kg bw in treated rats

Clinical signs:

other: 1.Clinical signs of systemic toxicity or reaction to treatment included lethargy, uncoordinated movements and staining of the eye on day 1. 2.No data available

Gross pathology:

1.No macroscopic abnormalities were noted during necropsy.
2.No data available

Other findings:

no data available

Interpretation of results:

other: not classified

Conclusions:

The test chemical Ferric hypophosphite (7783-84-8) is not likely to be toxic atleast in the dose range of 3850->5000 mg/kg bw.

Executive summary:

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Ferric hypophosphite (7783-84-8).The studies are as mentioned below:

1.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.

2.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 3850 mg/kg bw. Hence,LD50 value was considered to be 3850 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies,Ferric hypophosphite (7783-84-8)and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ferric hypophosphite (7783-84-8) cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical Ferric hypophosphite (7783-84-8)is not likely to be toxic atleast in the dose range of 3850->5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

data is from secondary source

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Ferric hypophosphite (7783-84-8).The studies are as mentioned below:

1.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.

2.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 3850 mg/kg bw. Hence,LD50 value was considered to be 3850 mg/kg bw,when rats were treated with test chemical orally.

Thus, based on the above summarised studies,Ferric hypophosphite (7783-84-8)and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ferric hypophosphite (7783-84-8) cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical Ferric hypophosphite (7783-84-8)is not likely to be toxic atleast in the dose range of 3850->5000 mg/kg bw.

Justification for classification or non-classification

Based on the above experimental studies on Ferric hypophosphite (7783-84-8)and it’s structurally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Ferric hypophosphite (7783-84-8)cannot be classified for acute oral toxicity.