Ammonium dihydrogen citrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting 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 434 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 434 (Acute Dermal Toxicity - Fixed Dose Procedure)

Deviations:

yes

Remarks:

Limited details on environmental conditions, no details on purity, no details on duration of exposure, open application

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:

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: no data
- Housing: Individually housed in stainless-steel cages
- 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

Type of coverage:

open

Vehicle:

other: water-acetone solution

Details on dermal exposure:

TEST SITE
Hair was first removed from an area of 3x4 cm^2 with an electric hair clipper, and the substance was applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate.

REMOVAL OF TEST SUBSTANCE
No data.

Duration of exposure:

No data

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 dermal toxicity study with ammonium sulfate in Wistar rats, performed equivalent to OECD434 test guideline, an LD50 >2000 mg/kg bw was determined.

Executive summary:

An assessment of acute dermal toxicity with Ammonium sulfate in the rat was performed equivalent to OECD434 test guideline. Ammonium sulfate was administered to the skin surface of the clipped backs of 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 dermal 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 dermal toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).