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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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