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EC number: 270-109-8 | CAS number: 68411-20-1
- 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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 407
- Principles of method if other than guideline:
- Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. At the end of the treatment period all animals were killed and a gross and microscopic examination of all major organs, including reproductive organs was conducted. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epidiymides, prostate, seminal vesicle coagulation gland, ovaries, and uterus.
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- Butanal, reaction products with aniline
- EC Number:
- 270-109-8
- EC Name:
- Butanal, reaction products with aniline
- Cas Number:
- 68411-20-1
- IUPAC Name:
- aniline; butanal
- Test material form:
- other: liquid
- Details on test material:
- Test Substance/Item
Test Item Butanal, reaction products with aniline
Aniline content 0,4%
CAS No. 68411-20-1
EC-No. 270-109-8
Chemical name Butanal, reaction products with aniline
CAS name Butanal, reaction products with aniline
Purity 96,6% (taken as 100%)
Appearance Liquid, yellow
Storage Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- At least 32 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 100 or 400 mg/kg body weight
Basis:
other: nominal
- No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- other:
- Remarks:
- No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).
Any other information on results incl. tables
There were no test substance-related toxic changes in organs weights of testes, epididymides, prostate, semical vesicle coagulation gland, ovaries, and uterus. No histopathological changes were found in testis, epididymides, prostate, seminal vesicle coagulation gland, ovaries and uterus.
Applicant's summary and conclusion
- Conclusions:
- No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).
- Executive summary:
Butanal, Reaction Products with Aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. At the end of the treatment period all animals were killed and a gross and microscopic examination of all major organs, including reproductive organs was conducted. The pathologic evaluation consisted of organ weight, gross and microscopic examination of reproductive organs, incl. testes, epidiymides, prostate, semical vesicle coagulation gland, ovaries, and uterus.
No evidence of toxicity to reproductive was observed in a subacute repeated dose study as no treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination. On the basis of this study no effects on fertility were expected (NOAEL, rat: 400 mg/kg bw/day).
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