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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No deficiencies, no guideline available.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
yes
Principles of method if other than guideline:
4 animals per treatment group were used (Guideline recommends 5 animals per group), samples were taken 6, 24 and 48 hours after treatment (Guideline recommends 12-18 hours after last dose), the reported mitotic index based on at least 500 cells (Guideline recommends 1000 cells), 50 metaphase spreads were scored for structural and numerical aberrations (Guideline recommends 50 cells), maximum tolerated dose not evaluated
GLP compliance:
not specified
Type of assay:
chromosome aberration assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium hypochlorite
EC Number:
231-668-3
EC Name:
Sodium hypochlorite
Cas Number:
7681-52-9
Molecular formula:
ClO.Na
IUPAC Name:
sodium hypochlorite
Details on test material:
App. 31 g/litre chlorine in stock solution; pH 8.5 (predominant chlorine species: OCl-) and 6.5 (predominant chlorine species: HOCl)

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals or test system and environmental conditions:
Source: Charles River Breeding Laboratories, Inc.8-11 weeks old, weight not stated

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
Distilled water
Details on exposure:
Concentration in vehicle: 0, 40, 100 and 200 mg/litre in chlorine equivalentsTotal volume applied: 1 mL
Duration of treatment / exposure:
Number of applications:a. acute: 1b. repeated dose test: 5
Frequency of treatment:
Interval between applications: 24 hours
Post exposure period:
6, 24 and 48 hours after acute dosing and 6 hours after the last repeated dosing
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:0, 1.6, 4.0 and 8.0 mg/kg bwBasis:nominal conc.acute test
Remarks:
Doses / Concentrations:0, 1.6, 4.0 and 8.0 mg/kg bw/day Basis:nominal conc.repeated dose test
No. of animals per sex per dose:
4
Control animals:
yes, concurrent vehicle
Positive control(s):
Triethylenemelamine (TEM) in 0.9 % saline: 1 mg/kg bw

Examinations

Tissues and cell types examined:
Clinical signs: NoTissue: Bone marrow
Details of tissue and slide preparation:
Number of animals: all animalsNumber of cells: 500Time points:a. acute dosing: 6, 24 and 48 hoursb. repeated dose test: 6 hoursType of cells: not statedParameters: endpoints were chromosomal aberrations (numerical, structural), percent cells with chromosomal aberrations

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
No significant differences from control in either structural or numerical chromosomal aberrations in case of acute and repeated dosing

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negativeFailure of Sodium hypochlorite to induce chromosomal aberrations in the bone marrow of mice shows a lack of clastogenic activity.

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