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EC number: 205-201-9 | CAS number: 135-57-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- DBD/RENACIT 10 was administered daily via gavage in Cremophor EL (2%)/tap water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 100, 300 or 1000 mg/kg body weight for a period of 4 weeks.
The animals were regularly observed and weighed. Food and water intake was determined. Functional Observational Battery (FOB) as well as Motor and Locomotor Activity (MA/LMA) tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed. - GLP compliance:
- yes
Test material
- Reference substance name:
- N,N'-dithiodi-o-phenylenedibenzamide
- EC Number:
- 205-201-9
- EC Name:
- N,N'-dithiodi-o-phenylenedibenzamide
- Cas Number:
- 135-57-9
- Molecular formula:
- C26H20N2O2S2
- IUPAC Name:
- N-{2-[(2-benzamidophenyl)disulfanyl]phenyl}benzamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test Item: DBD I RENACIT 10
Chemical name: N, N' -( dithiodi-2, 1-phenylene )bis-benzam ide
CAS No.: 135-57-9
Molecular Mass (g/mol): 456.59
Molecular Formula: C26H20N202S2
Content( s): 98.7%
Appearance: Gray, yellow powder
Storage: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Cremophor EL (2%)/tap water
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 29 (males)/30 (females) days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300 or 1000 mg/kg bw for a period of 4 weeks
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The survival rate, clinical appearance, body weight gain as well as food and water intake of the rats were not affected up to 1000 mg/kg.
FOB measurements and MA/LMA tests did not indicate neurotoxicity.
There was no indication of test substance-related changes in blood parameters. Beginning at 100 mg/kg an increase in liver weights was seen in males, which was correlated with liver enlargement. In females increased relative liver weights were noted at 1 000 mg/kg.
One of five males each showed distinct liver lobulation beginning at 300 mg/kg.
Centrilobular liver hypertrophy was diagnosed at 1000 mg/kg in males.
Taken together there were indications of adaptive liver reaction beginning at 100 mg/kg in males and at 1000 mg/kg in females.
The serum concentrations of sodium, potassium, were not affected by the treatment.
In the renal tubules of males at 300 mg/kg and above degenerations with increased accumulation of hyaline droplets, indicating a rat specific and not human relevant alpha-globulin nephropathy, was diagnosed. P2 and P3 segments of the cortical tubules were characterized by slight tubular dilation, luminal debris or cast and epithelial degeneration. Moreover, basophilic cortical tubules were raised by severity at 300 mglkg and above in males. Slight transitional cell hyperplasia occurred in the renal pelvis of 1/5 males each at 300 and 1000 mg/kg. In females, basophilic cortical tubules were slighty increased at 1000 mg/kg.
Taken together in the rat toxicologically relevant changes were evident in them kidneys beginning at 300 mg/kg in males and at 1000 mg/kg in females, where the alpha-globulin nephropathy and tubular basophilia are not supposed to be relevant for humans.
There was no morphological correlate to elevated heart weight of 1000 mg/kg males.
Necropsy, organ weight measurements and histopathology revealed no toxicologically relevant alterations in the remaining organs investigated.
Applicant's summary and conclusion
- Conclusions:
- Toxicologically relevant changes were evident in the kidneys beginning at 300 mg/kg in males and at 1000 mg/kg in females, where the alpha-globulin nephropathy and tubular basophilia are not supposed to be relevant for humans. Necropsy, organ weight measurements and histopathology revealed no toxicologically relevant alterations in the remaining organs investigated.
Therefore for humans a NOAEL of 1000 mg/kg bw is justified. - Executive summary:
DBD/RENACIT 10 was administered daily via gavage in Cremophor EL (2%)/tap water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 100, 300 or 1000 mg/kg body weight for a period of 4 weeks.
The animals were regularly observed and weighed. Food and water intake was determined. Functional Observational Battery (FOB) as well as Motor and Locomotor Activity (MA/LMA) tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.
The test substance was stable in the vehicle for the duration of use. Formulations given to the rats were prepared appropriately.
The survival rate, clinical appearance, body weight gain as well as food and water intake of the rats were not affected up to 1000 mg/kg.
FOB measurements and MA/LMA tests did not indicate neurotoxicity.
There was no indication of test substance-related changes in blood parameters. Beginning at 100 mg/kg an increase in liver weights was seen in males, which was correlated with liver enlargement. In females increased relative liver weights were noted at 1 000 mg/kg.
One of five males each showed distinct liver lobulation beginning at 300 mg/kg.
Centrilobular liver hypertrophy was diagnosed at 1000 mg/kg in males.
Taken together there were indications of adaptive liver reaction beginning at 100 mg/kg in males and at 1000 mg/kg in females.
The serum concentrations of sodium, potassium, were not affected by the treatment.
In the renal tubules of males at 300 mg/kg and above degenerations with increased accumulation of hyaline droplets, indicating a rat specific and not human relevant alpha-globulin nephropathy, was diagnosed. P2 and P3 segments of the cortical tubules were characterized by slight tubular dilation, luminal debris or cast and epithelial degeneration. Moreover, basophilic cortical tubules were raised by severity at 300 mglkg and above in males. Slight transitional cell hyperplasia occurred in the renal pelvis of 1/5 males each at 300 and 1000 mg/kg. In females, basophilic cortical tubules were slighty increased at 1000 mg/kg.
Taken together in the rat toxicologically relevant changes were evident in them kidneys beginning at 300 mg/kg in males and at 1000 mg/kg in females, where the alpha-globulin nephropathy and tubular basophilia are not supposed to be relevant for humans.
There was no morphological correlate to elevated heart weight of 1000 mg/kg males.
Necropsy, organ weight measurements and histopathology revealed no toxicologically relevant alterations in the remaining organs investigated.
Under the conditions described a no-observed-effect-level (NOEL) can not be determined for males due to adaptative changes in the liver considered to be not adverse. Deduced from species-specific kjdney alterations, the no-observed-adverse-effect-level (NOAEL) is assigned at 100 mg/kg for male and at 300 mg/kg (=NOEL) for female rats.
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