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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system, as the inhalation hazard test is insufficient for non-volatile substances.

Data source

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

Materials and methods

Principles of method if other than guideline:
The inhalation hazard test demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (usually 20°C). Several groups of usually 3 rats per sex were sequentially exposed to the vapors, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted disc in a glass cylinder for different time periods.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of the test substance weight loss during exposure. Group-wise documentation of clinical signs was performed over the 14 day study period. The study was conducted acc. to the method decribed by Smyth et al. 1962 with acceptable modifications.
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
Test type:
other: Inhalation Hazard Test

Test material

Constituent 1
Reference substance name:
Bis(hydroxylammonium) sulphate
EC Number:
233-118-8
EC Name:
Bis(hydroxylammonium) sulphate
Cas Number:
10039-54-0
IUPAC Name:
bis(hydroxyammonium) sulfate
Details on test material:
- Name of test material (as cited in study report): Hydroxylammoniumsulfat
- Physical state: solid (vapour pressure is negligible at 20 °C)
- 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
- Average weight at study initiation: experiment 1: ca. 216 g; experiment 2: ca. 218 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Saturation of the atmosphere was generated by conducting an air stream through a substance layer of 5 cm height at 20 °C.
The rats were exposed to the test atmosphere for 8 hours.
Air flow was 200 l/h in the exposure chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
The concentration was 0.0 mg/l (20 °C), no volatile parts of the test material were generated; the nominal concentration was calculated as quotient of the amount of the test substance weight loss during exposure.
No. of animals per sex per dose:
3 animals per sex per group
Control animals:
no
Details on study design:
The exposure time not causing lethality was tested twice.
- Duration of post exposure period until necropsy: 4 days
- Frequency of weighing: Test animals were weighed at test initiation and before sacrifice
- Frequency of observations: The animals were observed following exposure after 3 min, 10 min, 30 min, 1 hour, 3 hours, 7 hours and thereafter daily
- Necropsy of survivors performed: yes. The necropsy of the animals was done on day 4 following exposure

Results and discussion

Mortality:
All 12 animals survived after 8 h, and no deaths occurred in the postexposure period.
Clinical signs:
other: No symptoms were noted.
Body weight:
Mean body weight at the end of the study:
- IHT room temperature, 8 hours, experiment 1: 220.2 g
- IHT room temperature, 8 hours, experiment 2: 233 g
Gross pathology:
Autopsy revealed no relevant findings.
Other findings:
No formation of dust was seen.

Applicant's summary and conclusion