Registration Dossier
Registration Dossier
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EC number: 226-798-2 | CAS number: 5470-11-1
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: provide necessary infromation, contributing to assessment,
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- hydroxylamine hydrochloride
- IUPAC Name:
- hydroxylamine hydrochloride
- Test material form:
- not specified
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 15N
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 4 Sprague-Dawley rats (194 ± 7 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- 4 Sprague-Dawley rats (194 ± 7 g) were given a single dose of 20µmol15N-hydroxylamine hydrochloride (equivalent to about 7 mg/kg body weight) by stomach tube.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
20 µmol 15N-hydroxylamine hydrochloride (equivalent to about 7 mg/kg body weight)
- No. of animals per sex per dose / concentration:
- 4
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- The total elimination of15N-nitrate in the urine was 4.7% of the administered radioactivity. The largest proportion was found on day 4. The nitrate excretion was not increased after induction with 500 mg Arochlor 1254/kg body weight
Metabolite characterisation studies
- Metabolites identified:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
The total elimination of15N-nitrate in the urine was 4.7% of the administered radioactivity. The largest proportion was found on day 4. The nitrate excretion was not increased after induction with 500 mg Arochlor 1254/kg body weight. - Executive summary:
The metabolic oxidation of hydroxylamine hydrochloride in rats has been described. 4 Sprague-Dawley rats (194 ± 7 g) were given a single dose of 20µmol15N-hydroxylamine hydrochloride (equivalent to about 7 mg/kg body weight) by stomach tube. The total elimination of15N-nitrate in the urine was 4.7% of the administered radioactivity. The largest proportion was found on day 4. The nitrate excretion was not increased after induction with 500 mg Arochlor 1254/kg body weight.
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