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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
unsuitable test system
Remarks:
Unsuitable test system, as the inhalation hazard test is insufficient for non-volatile substances

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980
Reference Type:
publication
Title:
Range-finding toxicity data: List VI
Author:
Smyth, H.F. et al.
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J., 23, 95-107

Materials and methods

Principles of method if other than guideline:
Internal test method in accordance with Smyth HF et al., Am Ind Hyg Ass J 23: 95-107 (1962).
The inhalation hazard test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (usually 20°C). Several groups of usually 3 rats per sex were sequentially exposed to the vapours, 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.
GLP compliance:
no
Test type:
other: Inhalation hazrad test
Limit test:
yes

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:
Sulphate salt [10039-54-0], purity 99.5 % (not further
specified)

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Average weight at study initiation: experiment 1: males ca. 220 g, females ca. 160 g; experiment 2: males ca. 220 g, females ca. 160 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: 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 7 hours. Air flow was 200 L/h in the exposure chamber.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
saturated vapour exposure

The concentration was almost 0 mg/L at 20 °C (after 7 hours the difference in weight was ), 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:
12 per dose
Control animals:
no
Details on study design:
The exposure time not causing lethality was tested twice.
- Duration of post exposure period until necropsy: 14 days
- Frequency of weighing: Test animals were weighed at test initiation only
- 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 14 following exposure

Results and discussion

Mortality:
All animals survived within a 14-days observation period
Clinical signs:
other: no clinical signs were observed
Body weight:
The body weight was determined prior to the beginning of the study only.
Gross pathology:
Autopsy revealed no relevant findings.

Any other information on results incl. tables

 


 

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Since the result is depending on the vapour pressure of the test substance (being negligible at 20 °C for the tested material), an assessment of the inhalation toxicity is not possible. Nevertheless, the result supports the assumption that the test material is of low inhalation toxicity.