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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study is reliable with restrictions. Deficiencies are low animal number per dose group, purity of the test substance not stated, no PCE/NCE ratio given, and no toxic effects reported. However, due to the well reported test, the test institution with established reputation, and the publication in a peer-reviewed high quality journal the data is rated as reliable. Furthermore LD50 values for the test substance could be retrieved from other adequate acute toxicity studies.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Test performed according to: Schmid, W.: The micronucleus test for cytogenic analysis, in: A. Hollaender (Ed.), Chemical Mutagens, Vol. 4, 1976, 31-53.
Deviations:
not specified
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
, low animal number per dose group, purity of the test substance not stated, no PCE/NCE ratio given, and no toxic effects reported
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium sulfide
- Substance type: technical product
- Physical state: solid
- Test substance supplier: Merck Co., Darmstadt
No further details are given.

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Mice were obtained from S. Ivanovas GmbH and Co., KIsslegg/Allgäu (Germany).
- Diet: ad libitum, standard chow
- Water: ad libitum
No further details are given.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: 0.375M phosphate buffer, pH 7.2
Details on exposure:
Animals treated at 0 and 24 h, bone-marrow smears prepared at 30 h
Duration of treatment / exposure:
30 hours
Frequency of treatment:
The animals were treated at 0 and 24 hours.
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
96.1 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
48.0 mg/kg
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
24.0 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
4 mice (2 male and 2 female animals) were used for each dose.
Control animals:
yes
Positive control(s):
Pyrogallol, i.p.

Examinations

Tissues and cell types examined:
After 30 hours bone marrow smears were prepared.
Details of tissue and slide preparation:
Slides were coded and 1000 polychromatic erythrocytes were scored per mouse.
Statistics:
Significance was calculated according to the Kastenbaum-Bowman tables.

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
yes
Remarks:
One animal died in the 24 mg/kg dose-group.
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
not examined
Additional information on results:
Dose, MN PCE(%), Survival
0.0 mg/kg: 1.9, 4/4
24.0 mg/kg: 2.9, 3/4
48.0 mg/kg: 1.9, 4/4
96.1 mg/kg: 1.8, 4/4

-Positive control increased MN PCE ratio significantly and dose-dependent (low dose 3,8%, mid dose 14.7%, high dose 25.4%)
-No further toxic effects reported
-No PCE/NCE ratio given

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative In this study with sodium sulfide, no significant exerted mutagenic action was observed.
In this study with sodium sulfide, no significant exerted mutagenic action was observed.