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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1950
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted prior to establishment of standardised guidelines, also unclear calculations of LD50

Data source

Reference
Reference Type:
publication
Title:
On the Toxicity of Hydroxylamine
Author:
Riemann H.
Year:
1950
Bibliographic source:
Acta Pharmacol. 6:285-292

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
White mice (10/sex/dose) were orally administered hydroxylammonium hydrochloride and observed for 72 hours. No further details reported.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Hydroxylammonium hydrochloride
IUPAC Name:
Hydroxylammonium hydrochloride
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Hydroxylammonium hydrochloride.

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
Hydoxylammonium hydrochloride was given in 0.5 - 2 % aqueous solution so that the amount of liquid introduced for all the mice lay between 0.3 and 0.5 ml.
Doses:
200, 300, 400, 500 and 600 mg/kg.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 72 hours.
- Frequency of observations and weighing: Not stated.
- Necropsy of survivors performed: Not stated.
Statistics:
Not stated

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
approximate LD50
Effect level:
ca. 419 other: mg/kg
Based on:
dissolved
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 408 other: mg/kg
Based on:
dissolved
Mortality:
See table.
Clinical signs:
Not stated.
Body weight:
Not stated.
Gross pathology:
Methaemoglobin was observed in the dead animals.

Any other information on results incl. tables

Mortality of animals from the administration of different doses of hydroxylammonium hydrochloride.

Dose (mg/kg)

Mortality (male)

Mortality (female)

200

0/10

0/10

300

3/10

4/10

400

7/10

6/10

500

9/10

6/10

600

10/10

10/10

Calculated LD50 (mg/kg)

408

419

 

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The calculated LD50s are not reflective of the mortality observed in the study. The authors calculated an LD50 for male and female mice of 408 and 419 mg/kg. However from the mortality reported, the true LD50 should lie between the doses of 300 and 400 mg/kg for both male and female mice.
Executive summary:

In an acute oral toxicity study, groups of white mice (10/sex/dose) were given a single oral dose of hydroxlammonium hydrochloride at doses of 200, 300, 400, 500 and 600 mg/kg bw and observed for 72 hours. The authors calculated an LD50 for male and female mice of 408 and 419 mg/kg bw. However, the calculated LD50 is not reflective of the actual mortality reported in the study. The LD50 for both male and female mice was determined to be between 300 - 500 mg/kg bw. This reliability of this study is considered to be reliable with restrictions as the study was conducted prior to the establishment of standardised guidelines, however the calculated LD50s should be interpreted with caution.