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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: 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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).