Methoxyammonium chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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:

Internal method: 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.

Statistics:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

642 mg/kg bw

Based on:

test mat.

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:

convulsions

irregular respiration

observations of tremors

other:

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 that died during the study period.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the conditions of the test (similar to OECD guideline 401) for acute toxicity after oral application, the LD50 for hydroxylammoniumsulfat (pure grade) was 642 mg/kg body weight for male and female rats.

Executive summary:

In the present study, methods described in the OECD Guideline 401 were used. 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 applied gavage doses were 200, 400, 500, 640, 800, 1000, 1250, 1600 mg/kg bw. The LD50 value was estimated on the basis of the observed mortalities.

Clinical signs after exposure included tremor, convulsion, abdominal crouched down position, dyspnoe, dyspnoe, apathy, cyanosis, restless behaviour, stretching and slight twitching, shaggy fur and intermittent breathing, calm behavior. The animals that were sacrificed 7 days after administration of the test material and showed dark blue to violet or -black discolouration and enlargement of the spleen. The max. weight of the spleen was 2.0 g. Doses exceeding 200 mg/kg bw caused mortality. Under the conditions of the test for acute toxicity after oral application, the LD50 was 642 mg/kg body weight for male and female rats.