Ammonium iron bis(sulphate)

Endpoint summary

Description of key information

Since ammonium iron bis(sulphate) dissociates upon dissolution in aqueous media, the toxicity of this substance can be assessed by regarding the toxicity of ions formed. In studies regarding the acute oral toxicity of ammonium sulfate, ferric chloride and ferric ammonium citrate LD50 values between 1300 mg/kg bw and 5000 mg/kg bw were found. All the reported values correspond to doses of ammonium iron bis(sulphate) > 2000 mg/kg bw (2093 - 15400 mg/kg bw). Therefore, ammonium iron bis(sulphate) is not classified. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

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

Principles of method if other than guideline:

The authors propose a simple method for screening assessment of acute oral and dermal toxicity using only three rats and mice of each sex at each dose level. Animals were first treated with chemicals at a dose of 2000 mg/kg and were carefully observed for compound-related morbidity and mortality. If none of the animals died, the following toxicity tests were suspended. If some of the animals died, toxicity tests at doses of 200 and 20 mg/kg were performed.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age: 5 - 6 weeks

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

Animals were treated with the substances after at least 5 days of adaptation. The substance dissolved in water was administered orally in a single dose after fasting for 16 h.

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

All animals were individually housed in stainless-steel cages. Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days in the oral toxicity tests, and necropsy of all animals was carried out at the end of the test. Animal experiments were performed simultaneously in two different laboratories.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory A

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory B

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory A

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory B

Mortality:

Laboratory A: no dead animalsLaboratory B: 1 or 2 dead animals per sex

Interpretation of results:

GHS criteria not met

Conclusions:

According to laboratory A, LD50 (oral, rat) of ammonium sulfate is >2000 mg/kg body weight for both male and female rats. According to laboratory B, LD50 (oral, rat) of ammonium sulfate is ca. 2000 mg/kg body weight for both male and female rats.

Executive summary:

In this publication by Yamanaka et al. (published in 1990) a method for assessing the acute toxicity of chemicals is described. In a screening test, fixed doses of ammonium sulfate were administered orally to male and female rats with a maximum dose of 2000 mg/kg body weight. Experiments were performed simultaneously in two different laboratories. Laboratory A reported a LD50 of >2000 mg/kg bw for both male and female rats. Laboratory B reported a LD50 of ca. 2000 mg/kg bw for both male and female rat. The GHS criteria are not met by these results.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

no guideline followed

Principles of method if other than guideline:

The toxicity of iron salts is investigated by administering aqueous solutions of test material with various concentrations to mice. The study was cited in the OECD SIDS for iron salts.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

mouse

Strain:

other: Queckenbusch

Sex:

female

Details on test animals or test system and environmental conditions:

Animals were fasted for 19 hours before dosing.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Volume administered: 0.01 ml/g

Doses:

doses / mg Fe/kg body weight: 186, 335, 604, 1087doses / mg Ferric chloride/kg body weight: 540, 974, 1756, 3160

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

The animals were observed for at least 30 days after administration of the test material.

Sex:

female

Dose descriptor:

LD50

Effect level:

440 mg/kg bw

Based on:

element

Remarks:

Fe

95% CL:

>= 300 - <= 630

Sex:

female

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

Based on:

test mat.

Remarks:

FeCl3

95% CL:

>= 872 - <= 1 830

Mortality:

540 mg/kg bw FeCl3 - 1/10 deaths; 974 mg/kg bw FeCl3 - 2/10 deaths; 1756 mg/kg bw FeCl3 - 8/10 deaths; 3160 mg/kg bw FeCl3 - 10/10 deaths

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (oral, mouse) for ferric chloride is 1300 mg/kg body weight (440 mg Fe/kg body weight). This value corresponds to 2093 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met and ammonium iron bis(sulphate) is not classified.

Executive summary:

In this publication by Hosking (published in 1970) the oral toxicity of ferric chloride is assessed. Differently concentrated aqueous solutions of the test material was administered orally to female mice. From the mortality of the test animals LD50 can be developed. The LD50 (oral, mouse) for ferric chloride is 1300 mg/kg body weight (440 mg Fe/kg body weight). This value corresponds to 2093 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met and ammonium iron bis(sulphate) is not classified.

This study was cited by OECD in their SIDS Initial Assessment Report for SIAM 24.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The acute oral toxicity of some iron salts was investigated by administering the substances to test animals (mouse).

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

not specified

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (oral, mouse) for ferric ammonium citrate is 5000 mg/kg body weight. This value corresponds to ca. 5020 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met by this value, ammonium iron bis(sulphate) is not classified.

Executive summary:

In this article by Somers (published in 1947) experiments regarding the toxicity of some iron compounds are described. The test materials were administered orally to mice. LD50 (oral, mouse) of 5000 mg/kg bodyweight ferric ammonium citrate is reported. This value corresponds to ca. 5020 mg ammonium iron bis(sulphate) per kg body weight. Since the GHS criteria are not met by this value, ammonium iron bis(sulphate) is not classified.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 093 mg/kg bw

Justification for classification or non-classification

LD50, oral for ammonium iron bis(sulphate) is expected to be > 2000 mg/kg bw. Therefore, ammonium iron bis(sulphate) is not classified.