Fatty acids, C16-18 (even numbered), ammonium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

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

IUPAC Name:

diammonium sulfate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5-6 weeks old
- Housing: All animals were individually housed in stainless-steel cages.
- Acclimation period: At least, 5 days.

Administration / exposure

Type of coverage:

open

Vehicle:

other: water-acetone solution

Details on dermal exposure:

In the dermal toxicity test, hair was first removed from an area of 3 x 4 cm2 on the back of animals with an electric hair clipper, and then the chemical substance was dissolved in acetone and water and 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, and all animals were individually housed in stainless-steel cages.

Duration of exposure:

A single administration, but no data on removing.

Doses:

20, 200, and 2000 mg/kg bw.

No. of animals per sex per dose:

Three animals per sex and per dose.

Control animals:

not specified

Details on study design:

Careful observations of animals, including body weight changes, mortality figures, gross lesion and behavioural and clinical abnormality, were performed for 14 days.
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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Clinical signs:

No treatment-related clinical signs were observed.

Gross pathology:

No effects were observed at necropsy.

Any other information on results incl. tables

The LD50 was higher than 2000 mg/kg bw for rats after dermal application of ammonium sulfate.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified (CLP Regulation EC no. 1272/2008)

Conclusions:

The LD50 was greater than 2000 mg/kg bw for rats after dermal application of ammonium sulfate.

Executive summary:

An acute dermal toxicity test was performed on ammonium sulfate in accordance Toxicity Guidelines of Japan (Ministry of Health and Welfare in Japan, 1984). Three Wistar rats per sex and per dose were exposed to 20, 200, and 2000 mg/kg bw of test item. The chemical substance was dissolved in acetone and water and 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. No treatment-related clinical signs and necropsy findings were observed. The LD50 values higher than 2000 mg/kg bw are reported for rats after dermal application of ammonium sulfate.