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Toxicological information

Genetic toxicity: in vivo

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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:
1989
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

Constituent 1
Chemical structure
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

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