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EC number: 429-280-6 | CAS number: 151900-44-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subacute toxicity study according to OECD 407
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: subacute toxicity study done according to OECD Guideline 407
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 429-280-6
- EC Name:
- -
- Cas Number:
- 151900-44-6
- Molecular formula:
- Hill formula: C36H40N2S6 CAS formula: C36H40N2S6
- IUPAC Name:
- N,N-dibenzyl({6-[(dibenzylcarbamothioyl)disulfanyl]hexyl}disulfanyl)carbothioamide
- Details on test material:
- Purity: 99.66 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH
- Age at study initiation: 5 to 6 weeks
- Fasting period before study:
- Housing:animals were housed individually in type II A-cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 5%
- Air changes (per hr): 15 to 20 changes per hour
- Photoperiod: 12hrs dark / 12hrs light)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- the test substance was administered by gavage from the start of the study until day 27 for the recovery groups and until the day before scheduled sacrifice for the main group
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- during the study period, the test substance content in the vehicle was checked two times, determination of the test substance solved in corn oil was done by HPLC, homogeneity tested prior study and during study
- Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- 28 d repeated dose study
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200, 1000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 40 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 40 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Main group: 0, 40, 200, 1000 mg/kg, 5 animals/dose/sex
Recovery group (14 d recovery period): 0, 1000 mg/kg 5 animals/dose group - Positive control:
- none
Examinations
- Statistics:
- Dunnett test, p value adjusted Welch test, Kruskal-Wallis test, Mann-Whitney.Wilcoxon test (U tests)
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No effects in organ weights, gross pathology and histology in the sex organs evaluated
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Clinical observations: No mortality occurred during the study period.
There were no changes in clinical appearance, functional observations, body weights, and food consumption
The functional observations showed no signs or symptoms indicating evidence for systemic toxic and neurotoxic potential. Grip strength and motor activity measurements exhibited no treatment-related changes in both sexes at doses of 1000 mg/kg bw/d and below.
Laboratory findings: There were no biological significant effects of treatment on hematological and biochemical parameters. For a small number of parameters the differences between control and test groups attained a degree of statistical significance. However, the differences were small, not dose-related and inconsistent between the sexes.
Effects in organs: There were no treatment-related findings in organ weights, gross or microscopic pathology in rats of both sexes given 1000 mg/kg bw/d and below. Histopathological changes seen were of a minor nature and at a similar level to those seen in the controls.
No effects in organ weights, gross pathology and histology in the sex organs evaluated (epididymides, ovaries, oviducts, prostate, testes, uterus with uterine cervix, vagina)
Applicant's summary and conclusion
- Executive summary:
In a subacute toxicity study the test substance Vulcuren Trial Product KA 9188 was administered orally via gavage to male and female Wistar rats at target concentrations of 0, 40, 200 and 1000 mg/kg body weight for about 4 weeks. In parallel male and female rats (5 per sex and group) were treated with 0 and 1000 mg/kg body weight. These rats were observed for reversibility, continuance or delay occurrence of toxic effects during a recovery period of about 2 weeks. No differences regarding the survival rat or general behavior were noted compared to the untreated animals. In addition, no relevant differences were observed in mean feed intake and weight gain in any of the treatment groups evaluated compared to the negative control. No neuronal behavior effects were noted in any of the treatment groups. There were no toxicologically relevant changes in haematology and clinical chemistry in animals treated with the test compound. No biologically relevant effects on the organ weights were found in any of the rats treated with the test substance compared to the control animals.There was no evidence of any gross pathological and histopathological findings associated to dosing with the test compound up to the highest dose group (1000 mg/kg body weight) in both genders. In addition, no substance-related effects were noted in the evaluated sex organs. The author concluded that the administration of Vulcuren Trial Product KA 9188 to male and female Wistar rats for about 4 weeks was tolerated without adverse effects up to and including 1000 mg/kg. No delayed occurrence of toxic effects was observed during a recovery period of about 2 weeks (Bayer AG 2000d).
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