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Toxicological information

Acute Toxicity: dermal

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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: limited documentation, open publication, no further information on purity

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Version / remarks:
Litchfield-Wilcoxon method
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium sulphate
EC Number:
231-984-1
EC Name:
Ammonium sulphate
Cas Number:
7783-20-2
Molecular formula:
H3N.1/2H2O4S ; H8N2O4S ; (NH4)2SO4
IUPAC Name:
ammonium sulfate / ammonium sulphate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
male and female Wistar rats
aged 5-6 weeks at study initiation
individually housed in stainless-steel cages.
acclimatisation period: at least 5 days

Administration / exposure

Type of coverage:
open
Vehicle:
other: acetone and water
Remarks:
no further details given
Details on dermal exposure:
Area of exposure: back
Hair was first removed from an area of 3 x 4 cm2 from the back of rats with an electric clipper. Then the test substance dissolved in acetone and water was in a single dose to the skin surface of the animals' clipped backs. The application sites were not covered but the treated areas were prevented being licked by using plastic collars or by fixing the animals on a plastic plate.
Duration of exposure:
no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
Duration of observation period following the administration: 14 days
Careful observation of animals, including body weight changes, mortality figures, gross lesion and behaviour and clinical abnormialty.
Necropsy of all animals (outlived and dead)
Statistics:
Tests were simultaniously performed in two laboratries.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: determined in both laboratories
Remarks:
limit test
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: determined in both laboratories
Remarks:
limit test
Mortality:
no deaths
Clinical signs:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Conclusions:
Based on this accute dermal toxicity study on rats with ammonium sulfate the LC50 was determined for each sex as > 2000 mg/kg bw.
Executive summary:

The test substance was administered three female and three male Wistar rats at a dose level of 2000 mg/kg bw. They were observed for 14 days. Observation and examination included clinical and behavioural abnormalities, body weight, mortality, and gross lesions.

All animals were subjected to necropsy

Based on this accute dermal toxicity study the LC50 was determined individually for each sex as > 2000 mg/kg bw determined in both laboratories.

No adverse effects were reported.