Bis(hydroxylammonium) sulphate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

BASF-Test: In principle, the methods described in the OECD Guideline 401 were used. Young adult laboratory rats were purchased from breeder. Several groups of 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 14 day study period. The LD50 value was estimated on the basis of the observed mortalities.

GLP compliance:

no

Remarks:

GLP was not compulsory at the time the study was conducted.

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(hydroxylammonium) sulphate

EC Number:

233-118-8

EC Name:

Bis(hydroxylammonium) sulphate

Cas Number:

10039-54-0

Molecular formula:

H3NO.1/2H2O4S

IUPAC Name:

bis(hydroxyammonium) sulfate

Details on test material:

- Name of test material (as cited in study report): Hydroxylammoniumsulfat
- Analytical purity: pure grade

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gassner
- Average weight at study initiation: males: 219 g, females: 173 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Concentration in vehicle: 16 % (1600 mg/kg bw), 10 % (1250 and 1000 mg/kg bw), 8 % (800 mg/kg bw), 4 % (400 mg/kg bw), 2 % (200 mg/kg bw) in Aqua dest.

Doses:

200, 400, 500, 640, 800, 1000, 1250, 1600 mg/kg bw

No. of animals per sex per dose:

10 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations: Animals were observed and examined for clinical signs of toxicity during the first hour following application, after 4 and 5 hours and further daily on working days.
- The body weights of the individual animals were gathered prior to application of the test material.
- Necropsy of survivors performed: Deceased animals and those sacrificed at the end of the observation period (on day 7 after dosing) were necropsied.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

642 mg/kg bw

Mortality:

Mortality ratio:

Dose
(mg/kg bw) - 1 hour - 24 hours - 48 hours - 7 days
-----------------------------------------------
1600 - 20/20 - 20/20 - 20/20 - 20/20
1250 - 17/20 - 18/20 - 18/20 - 18/20
1000 - 12/20 - 15/20 - 15/20 - 15/20
800 - 07/20 - 10/20 - 10/20 - 10/20
640 - 12/20 - 13/20 - 13/20 - 13/20
500 - 03/20 - 06/20 - 06/20 - 06/20
400 - 00/20 - 01/20 - 01/20 - 01/20
200 - 00/20 - 00/20 - 00/20 - 00/20

Clinical signs:

other: Observed Symptoms: 200 mg/kg: --------- Immediately after application of the test material: tremor, abdominal crouched down position, dyspnoe; without any findings after 3 days 400 - 800 mg/kg: -------------- Immediately after application of the test m

Gross pathology:

Organpathology (animals that were sacrificed 7 days after administration of the test material):
dark blue to violet or -black discolouration and enlargement of the spleen. The max. weight of the spleen was 2.0 g.
No detailled gross pathology findings were available from those animals taht died during the study period.