Iron(II) fumarate

Endpoint summary

Description of key information

Acute toxicity oral

In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.

Acute toxicity inhalation

The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver

 

Acute toxicity dermal

The study doesnot need to be conducted because skin contact in production and/or use is not likely. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from handbook

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of the test chemical in rats

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

3850 mg/kg bw

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

3 850 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 50 % mortality observed

Mortality:

50 % mortality was observed in treated rats

Clinical signs:

not specified

Body weight:

not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.

Executive summary:

In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 850 mg/kg bw

Quality of whole database:

Klimisch Rating 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because skin contact in production and/or use is not likely

Endpoint conclusion

Endpoint conclusion:

no study available

Quality of whole database:

waiver

Additional information

Acute toxicity oral

Various studies have been reviewed to evaluate the oral toxicity potential of the test chemical. These include in vivo experimental studies performed on rats as well as mice for the test chemical. The results are mentioned below:

In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally.

This result is supported by another similar acute oral toxicity study where,rats were treated with the test chemical orally. No mortality was observed in treated rats at 2300 mg/kg bw. Therefore, LD50 was considered to be greater than 2300 mg/kgbw when rats were treated with the test chemical orally.

The above results are further strengthened by a similar acute oral toxicity study where, WAG albino male rats were treated with the test chemical orally. 50 % mortality was observed at 580 mg/kg. Therefore, LD50 was considered to be 580 mg/kg when WAG albino male rats were treated with the test chemical orally.

All of the above results are supported by an acute oral toxicity study performed on mice. The metal content [Fe] present in the test chemical was 33%. The test chemical was given as an aqueous suspension containing 0.1% w/v of tragacanth. Groups of 10 male fawn mice (GFF strain, bodyweights 17 to 22 gm. ) were dosed orally and then observed for seven days, when the percentage mortalities were recorded. The LD50 values, which were calculated according to do Beer (1945) and expressed in nig. Fe/Kg. LD50 was considered to be 630 mg/kg when Fawn GFF male mice were treated with the test chemical orally.

Eventhough some studies indicate that the test chemical can cause toxicity to standard test organisms when dosed orally, but majority of the studies point out to the fact that the test chemical is non toxic. Hence, the acute oral LD50 for the test chemical can be considered to be greater than 2000 mg/kg and can be classified under the category “Not Classified” as per CLP Regulation.

Acute toxicity inhalation

The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver

 

Acute toxicity dermal

The study doesnot need to be conducted because skin contact in production and/or use is not likely. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver.

 

Justification for classification or non-classification

Based on the available results, the test chemical can be regarded as non-toxic when dosed via oral, inhalation, dermal route of exposure. Hence, it can be classified under category "Not Classified" as per CLP Regulation.