Registration Dossier
Registration Dossier
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EC number: 214-071-2 | CAS number: 1077-28-7
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-19 - 1995-09-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Study owner prepared study while seeking authorisation of the substance as active incredient for medical treatment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
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:
- other: in vivo micronucleus test
Test material
- Reference substance name:
- 5-(dithiolan-3-yl)valeric acid
- EC Number:
- 214-071-2
- EC Name:
- 5-(dithiolan-3-yl)valeric acid
- Cas Number:
- 1077-28-7
- Molecular formula:
- C8H14O2S2
- IUPAC Name:
- 5-(1,2-dithiolan-3-yl)pentanoic acid
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: bulk
- Details on test material:
- This composition is the usual techical grade of AlzChem AG. It will be used when test substance has this composition (or is very closed) or no specific information is available
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Caging: Macrolon cages, type II
Animals per cage: 1
Bedding: Animal bedding softwood garnulation HW 300/500W
Diet: Standard diet ad libitum
Water: ad libitum
Room temperature: 21.0 - 22.0 °C
Relative humidity: 48 - 52 %
Room lighting: 6:00 - 18:00 (cet) artificial lighting
18:00 - 6:00 (cet) darknes
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Frequency of treatment:
- single administration
- Post exposure period:
- 24 h and 48 h
Doses / concentrations
- Dose / conc.:
- 825 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Negative control: 12 m + 12 f
Positive control: 6 m + 6 f
Test material group: 19 m + 17 f - Control animals:
- yes
- Positive control(s):
- Cyclophosphamid
Examinations
- Tissues and cell types examined:
- Bone marrow cells from both femurs.
Polychromatic erythrocytes - Details of tissue and slide preparation:
- Bone marrow was suspended in approx. 1.5 ml FCS and centrifuged at 180 g for 5 min.
Supernatand was discarded and cells were suspended in FCS.
Small drop of this suspension was smeared on a slide and dried overnight. - Statistics:
- POISSON test
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- ten test material group animals died
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Thioctic acid, racemate, at 825 mg/kg body weight (males and females, single oral administration) is non-genotoxic in the mouse micronucleus test under the described conditions.
- Executive summary:
Ten (10) test mateial group animals died.
After a singele oral admission of the test material à 825 mg/kg b. w. no statistically significant test material-related increase im micronucleated PCEs was observed in both, male and female animals, respectively males and females combined, when compared with corresponding negative control group animals at 24 h or 48 h after administration. No reduction in PCE/NCE ratio was present in test material group animals, when compared to the corresponding control group animals.
The positive control group animals, wich recieved cyclophosphamide, exhibited a significant increase in the number of micronucleated polychromatic erythrocytes and thus validated the test system.
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