Registration Dossier
Registration Dossier
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EC number: 215-185-5 | CAS number: 1310-73-2
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: According to the OECD SIDS document for sodium hydroxide (March 2002), a Klimisch 3 reliability score was assigned since the documentation is insufficient for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Mouse Bone Marrow Micronucleus Test: Evaluation of 21 Drug Candidates
- Author:
- Aaron et al.
- Year:
- 1 989
- Bibliographic source:
- Mutation Research 223, 129-140
Materials and methods
- Principles of method if other than guideline:
- The test compound was administered as a single i.p. dose to treatment groups (5 males and 5 females) for sacrifice at 30, 48 and 72 hours. NaOH was used as control substance.
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
Doses / concentrations
- Dose / conc.:
- 10 mg/kg bw/day
- Remarks:
- 10 mg/kg of 15 mM NaOH
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- other: no significant increase of nuclei was observed
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
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