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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:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-thiol 1-oxide, sodium salt
EC Number:
223-296-5
EC Name:
Pyridine-2-thiol 1-oxide, sodium salt
Cas Number:
3811-73-2
Molecular formula:
C5H5NOS.Na
IUPAC Name:
sodium (1-oxo-1λ⁵-pyridin-2-yl)sulfanide
Details on test material:
- Analytical purity: 92.5%
- Lot/batch No.: SB-D010010

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River WIGA GmbH
- Age at study initiation: 9 weeks
- Weight at study initiation: male 28.3-29.5g female 26.3-27.9g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Frequency of treatment:
1
Post exposure period:
-Post exposure period: 24 and 48h
Doses / concentrations
Remarks:
Doses / Concentrations:
400, 482, 580 mg/kg bw
Basis:

No. of animals per sex per dose:
5m + 5f per dose and sampling time
Control animals:
yes, concurrent vehicle
Positive control(s):
Cyclophophamide (monohydrate), 40 mg/kg bw.

Examinations

Tissues and cell types examined:
-Bone marrow
Evaluation criteria:
Polychromatic/normochromatic erythrocytes ratio
Micronucleated erythrocytes

Results and discussion

Additional information on results:
No statistically significant increase in the amounts of micronucleated polychromatic erythrocytes was observed at any dose tested compared to the negative controls, neither 24 nor 48 hours after treatment, neither for males nor for females. Bioavailability of the test substance was proven by mortality and by cytotoxicity at the high dose.

Applicant's summary and conclusion

Conclusions:
The test substance does not produce relevant increases of the numbers of micronuclei in polychromatic erythrocytes after in vivo treatment of mice of either sex of the test strain at doses of 400, 482 and 580 mg/kg bw. The information contained within this robust summary document comes from studies which are in the ownership of Arch Chemicals Inc. and which are protected in several regions globally. This information may not be used for any purpose other than in support of the Chemical safety Report submitted by Arch Chemicals Inc. under Regulation EC 1907/2006.