Registration Dossier
Registration Dossier
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EC number: 934-716-8 | CAS number: -
Genetic toxicity: in vivo
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 for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- 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
- 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 substance name:
- Disodium sulphide
- EC Number:
- 215-211-5
- EC Name:
- Disodium sulphide
- Cas Number:
- 1313-82-2
- Molecular formula:
- Na2S
- IUPAC Name:
- disodium sulfide
- 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.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system 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.
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