Ammonium dihydrogen citrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: In this publication an acute oral toxicity test was conducted using a similar OECDTG 423 protocol without GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

Limited details on test animals and environmental conditions, no details on purity

GLP compliance:

no

Test type:

acute toxic class method

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:

H8N2O4S

IUPAC Name:

diammonium sulfate

Test material form:

not specified

Details on test material:

Ammonium sulfate
CAS No.: 7783-20-2
NIOSH No.: BS4500000

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: no data
- Fasting period before study: 16 hours
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
No data

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION: The test substance was dissolved in water

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
- Necropsy of survivors performed: yes

Statistics:

Not performed.

Results and discussion

Preliminary study:

Not performed.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

No data.

Body weight:

No data.

Gross pathology:

No data.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

According to Regulation (EC) No. 1272/2008.

Conclusions:

In an acute oral toxicity study with Ammonium sulfate in Wistar rats, performed equivalent to OECD423 test guideline, an LD50 >2000 mg/kg bw was determined.

Executive summary:

An assessment of acute oral toxicity with Ammonium sulfate in the rat was performed equivalent to OECD423 test guideline. Ammonium sulfate was administired by oral gavage to 3 male and 3 female Wistar rats at 2000 mg/kg bw. Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days. All animals were subjected to necropsy. No mortality occured. Based on the results of the study, the oral LD50 was >2000 mg/kg body weight. Based on these results, Ammonium sulfate does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).