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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There is no fertility study with butanal, reaction products with aniline available.
Repeated dose toxicity: 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).
Screening study:
According to Regulation (EC) No 1907/2006 Annex VIII 8.7.1 a screening for reproductive/developmental toxicity, one species (OECD 421 or 422) is required, if there is no evidence from available information on structurally related substances, from (Q)SAR estimates or from in vitro methods that the substance may be a developmental toxicant.
The substance used to be registered in the tonnage band 100-1000 t and a testing proposal for a developmental toxicity study according to OECD 414 had been included in a testing proposal. With the reduction of the tonnage band to 10-100 t the OECD 414 is no longer needed.
A screening study according OECD TG 421 is therefore planned
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Short description of key information:
There was no fertility study with butanal, reaction products with
aniline available. No effects on reproductive organs were observed in a
28 day study in rats. 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. No treatment-related changes were observed for any
reproductive organ investigated during macroscopic and microscopic
examination of all major organs (NOAEL, rat: 400 mg/kg bw/day; males and
females).
Effects on developmental toxicity
Description of key information
A study according OECD TG 421 is planned
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Description of key information
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.
Link to relevant study records
- 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
- 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
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- At least 32 days
- Frequency of treatment:
- Daily
- 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
- 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).
- 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).
Reference
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.
Additional information
No effects on reproductive organs were observed in a 28 day study in rats. 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 treatment-related changes were observed for any reproductive organ investigated during macroscopic and microscopic examination of all major organs (NOAEL, rat: 400 mg/kg bw/day; males and females).
There were no test substance-related toxic changes in organs weights of testes, epididymides, prostate, seminal vesicle coagulation gland, ovaries, and uterus. No histopathological changes were found in testis, epididymides, prostate, seminal vesicle coagulation gland, ovaries and uterus.
Justification for classification or non-classification
There are no studies for toxicity to reproduction and/or developmental toxicity available.
A screening OECD TG 421 is therefore planned.
A classification/non-classifiation according to CLP classification criteria (Regulation (EC) No 1272/2008) will be done after the availability of the screening toxicity study (OECD TG 421).
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.