Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
BASF-Test:
Young adult laboratory mice were purchased from breeder. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The substance was injected into the peritoneal cavity. The concentrations of the preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the study period of 14 days.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
mouse
Strain:
other: Kisslegg-mice
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation:
mean body weight, males: 28 g
mean body weight, females: 22 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
DOSAGE PREPARATION (w/v):
0.5 % for the 25 and 50 mg/kg bw dose group
1 % for the 100 mg/kg bw dose group
1 % for the 72.7 mg/kg bw dose group, dose volume applied: 10 ml/kg bw
2 % for the 125, 160 and 200 mg/kg bw dose group
16 % for the 1600 mg/kg bw dose group

Doses:
25, 50, 100, 125, 160, 200 and 1600 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose.
Control animals:
no
Details on study design:
Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
Animals were observed and examined for clinical signs of toxicity during the first hour following application, after 2, 4 and 5 hours and further daily on working days after dosing.
Body weights were determined prior to application of the test material.

- Necropsy of survivors performed: yes
Deceased animals and those sacrificed at the end of the observation period were necropsied.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 142 mg/kg bw
Remarks on result:
other: after 24 h as well as after 7 days.
Mortality:
No mortality occured in the 25, 50 and 100 mg/kg bw dose groups. In the 125 mg/kg bw group 3/10 animals died within the first hour after application of the test material. No further animals died until the end of the observation period on day 7. In the 160 mg/kg bw group 8/10 animals died within the first hour after application of the test material. No further animals died until the end of the observation period on day 7. In the 200 mg/kg bw group 9/10 animals died within the first hour after application of the test material. No further animals died until the end of the observation period on day 7. In the 1600 mg/kg bw group 9/10 animals died within the first hour after application of the test material. No further animals died until the end of the observation period on day 7.
Clinical signs:
25 - 100 mg/kg bw:
Immediately after injection of the test material intermittent breath, abdominal position, cyanosis, closed eyelids and within intervals slight convulsions were seen. From the 3rd day onward only slight and further on no more findings were seen.

125 - 160 mg/kg bw:
Immediately after injection of the test material tremor and stretching was noted, in the 125 mg/kg bw group dyspnea and cyanosis were additionally seen, followed by exitus. After 15 minutes the surviving animals were in an abdominal position with intermittent breath and apathy. On the following day accelerated breath and unkempt fur was seen. On day 4 the surviving animals were without any findings.
200 - 1600 mg/kg bw:
Immediately after injection of the test material cunvulsions and dyspnea were seen, followed by exitus. The surviving animals was without any findings from day 3 onward.
Body weight:
The body weight of the animals was determined prior to application of the test material only.
Gross pathology:
Autopsy revealed no relevant findings.

Applicant's summary and conclusion