Ammonium iron bis(sulphate)

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

A simple method for screening assessment of acute toxicity of chemicals

Author:

S. Yamanaka, M. Hashimoto, M. Tobe, K. Kobayashi, J. Sekizawa, M. Nishimura

Year:

1990

Bibliographic source:

Archives of Toxicology, 64, 1990, 262-268

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H3N.1/2H2O4S

IUPAC Name:

diammonium sulfate

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age: 5 - 6 weeks

Administration / exposure

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.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory A

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory B

Effect levels 3

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: laboratory A

Effect levels 4

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

Applicant's summary and conclusion

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.