Chlorine

Genetic toxicity: in vivo

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

Test material information

Constituent 1

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 / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:0, 1.6, 4.0 and 8.0 mg/kg bwBasis:nominal conc.acute test

Doses / concentrations 2

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.