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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: Data sharing dispute
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:
Genotoxicity activity and potency of 135 compounds in the Ames reversion test in a bacterial DNA-repair test
Author:
De Flora et al.
Year:
1984
Bibliographic source:
Mutation Research, 133: 161-198

Materials and methods

Principles of method if other than guideline:
other (not specified)
GLP compliance:
no
Type of assay:
bacterial reverse mutation 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
Details on test material:
no data

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
not specified
Details on test system and experimental conditions:
Ames test

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion