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Repeated dose toxicity: other routes

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Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2007
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Abstract available only, full publication in Chinese
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other: Publication abstract
Title:
Acute toxicity and target organs assessment of subchronic exposure to hydroxylammonium nitrate in Wistar rats
Author:
An H., Liu S-X., G L-H., Ran H., Huan Y., Cao J.
Year:
2007
Bibliographic source:
Journal of Toxicology

Materials and methods

GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hydroxylammonium nitrate
EC Number:
236-691-2
EC Name:
Hydroxylammonium nitrate
Cas Number:
13465-08-2
Molecular formula:
H3NO.HNO3
IUPAC Name:
hydroxylammonium nitrate

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: 0.9% saline
Details on exposure:
Rats were administered hydroxylammonium nitrate
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Not stated
Doses / concentrations
Remarks:
Doses / Concentrations:
0.00 (control), 7, 14, 28 mg/kg bw/day
No. of animals per sex per dose:
Not stated
Control animals:
yes, concurrent vehicle
Details on study design:
Rats were administered hydroxylammonium nitrate at doses of 0.00 (control), 7, 14 and 28 mg/kg for 13 weeks. After the last dose, 75% of the animals were sacrificed by cervical dislocation, the remaining animals were allowed a recovery period before sacrifice.

Examinations

Observations and examinations performed and frequency:
Not stated
Sacrifice and pathology:
Animals were sacrificed by cervical dislocation at either at the end of the treatment period (13 weeks) or after the treatment period and a recovery period (time not stated). The main target organs of subchronic exposure to HAN were evaluated.
Other examinations:
Not stated.
Statistics:
Not stated.

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Spleen weight was significantly higher in animals administered hydroxylammonium nitrate for all doses.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Significant lesions occurred mainly in the lung, liver and spleen in animals administered hydroxylammonium nitrate.
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Large deposits of hemosidering in the liver, spleen and kidneys in animals administered hydroxylammonium nitrate.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Rats administered hydroxylammonium nitrate via intraperitoneal injection at concentrations of 7, 14 and 28 mg/kg for 13 weeks displayed lesions in the lung, liver and spleen and had large hemosiderin deposits in the liver, spleen and kidney. There were no significant differences in bodyweight between control and experimental animals, although all concentrations of hydroxylammonium nitrate caused an increase in spleen weight in the experimental animals compared to control animals. There is no evaluation of the animals who were given a recovery period. A LOAEL of 7 mg/kg can be derived from this study based on changes in spleen weight.
Executive summary:

Rats administered hydroxylammonium nitrate via intraperitoneal injection at concentrations of 7, 14 and 28 mg/kg for 13 weeks displayed lesions in the lung, liver and spleen and had large hemosiderin deposits in the liver, spleen and kidney. There were no significant differences in bodyweight between control and experimental animals, although all concentrations of hydroxylammonium nitrate caused an increase in spleen weight in the experimental animals compared to control animals. A LOAEL of 7 mg/kg can be derived from this study based on changes in spleen weight. The reliability of this study is not assignable.