Registration Dossier
Registration Dossier
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EC number: 226-798-2 | CAS number: 5470-11-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Meets generally accepted scientific principles. But route of application (subcutaneous) is not in line with international guidelines and therefore not acceptable for the assessment of acute dermal toxicity. The present study may only be used as worst case assessment and support for the waiving argumentation.
Data source
Reference
- Reference Type:
- publication
- Title:
- Zur Pharmakologie von Hydrazinokarbonsäuren, Hydrazinopeptiden und anderen Hydrazinderivaten
- Author:
- Oehme, P. et al.
- Year:
- 1 968
- Bibliographic source:
- Acta biol. med. germ. 21: 635 - 647
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: Test item was applied subcutaneously
- Parameters analysed / observed: LD 50 - GLP compliance:
- not specified
- Test type:
- standard acute method
Test material
- Reference substance name:
- Hydroxylammonium chloride
- EC Number:
- 226-798-2
- EC Name:
- Hydroxylammonium chloride
- Cas Number:
- 5470-11-1
- Molecular formula:
- ClH.H3NO
- IUPAC Name:
- hydroxyammonium chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Agnes-Blum
- Sex:
- female
Administration / exposure
- Type of coverage:
- other: subcutaneous application
- Vehicle:
- not specified
- Duration of exposure:
- 24 h
- Doses:
- 3 different doses
- No. of animals per sex per dose:
- 10 females
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 125.08 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: effect level calculated from 1.8 mMol/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 4 based on CLP/EU GHS criteria, according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: Acute Dermal 4, H312 (Annex VI harmonized classification)
The subcutaneous application of the test substance can be considered as worst case demonstrating the hazardous potential of hydroxylammonium chloride which is in line with the harmonized classification.
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