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Diss Factsheets
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EC number: 270-485-3 | CAS number: 68442-68-2
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- SCREENING-LEVEL HAZARD CHARACTERIZATION, Substituted Diphenylamines Category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency, Hazard Characterization Document, September, 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline
- Principles of method if other than guideline:
- To evaluate the toxicity of Benzenamine, N-phenyl-, styrenated in Sprague-Dawley rats by combined repeate dose/reproductive/developmental toxicity screening test.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, styrenated
- EC Number:
- 270-485-3
- EC Name:
- Benzenamine, N-phenyl-, styrenated
- Cas Number:
- 68442-68-2
- Molecular formula:
- not applicable (UVCB substance)
- IUPAC Name:
- 4-(1-phenylethyl)-N-[4-(1-phenylethyl)phenyl]aniline
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzenamine, N-phenyl-, styrenated- Molecular formula (if other than submission substance): No data available- Molecular weight (if other than submission substance): 320g/mol- Substance type: Organic- Physical state: Liquid- Impurities (identity and concentrations): No data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- No data available.
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Benzenamine, N-phenyl-, styrenated suspension in corn oil at 0, 50, 250 and 600 mg/kg-bw/day were prepared. DIET PREPARATION- Rate of preparation of diet (frequency): No data available - Mixing appropriate amounts with (Type of food): No data available- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): Corn oil - Concentration in vehicle: 0, 50, 250 and 600 mg/kg-bw/day - Amount of vehicle (if gavage): No data available- Lot/batch no. (if required): No data available- Purity: No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Details on mating procedure:
- - Impregnation procedure: [artificial insemination / purchased timed pregnant / cohoused]: No data available.- If cohoused: No data available.- M/F ratio per cage: 1: 1 ratio - Length of cohabitation: 15 days - After ... days of unsuccessful pairing replacement of first male by another male with proven fertility: No data available.- Further matings after two unsuccessful attempts: [no / yes (explain)]: No data available.- Verification of same strain and source of both sexes: [yes / no (explain)]: No data available.- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: No data available.- Any other deviations from standard protocol: No data available.
- Frequency of treatment:
- Daily
- Duration of test:
- 43 days for male 53 days for female(14 days –Pre-mating, 14 days mating period,21 days of Gestation,4 days of Lactation)
- No. of animals per sex per dose:
- Total no. of animals 800 mg/kg-bw/day – 10 male and 10 female50 mg/kg-bw/day- 10 male and 10 female250 mg/kg-bw/day -10 male and 10 female600 mg/kg-bw/day -10 male and 10 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available.
Examinations
- Maternal examinations:
- Survival, clinical sign, body weight, food consumption, water consumption, clinical chemistry, Organ weight, gross pathology and gross pathology were observed.
- Ovaries and uterine content:
- Pre-implantation losses was observed.
- Fetal examinations:
- Clinical sign, body weight and surface righting and macroscopic abnormality were observed.
- Statistics:
- No data available.
- Indices:
- Fertility and gestation were observed
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yesDetails on maternal toxic effects:Mortality : No mortality were observed in treated group.Clinical signs : No treatment-related changes in behavioral were observed in treatment groups.Body weight:No effect was observed on body weight of treated rats. Food consumption:No effect was observed on food consumption of treated rats.Water consumption:No effect was observed on water consumption of treated rats.Clinical chemistry:Decreased cholesterol levels was observed in male rats at 250 and 600 mg/kg bw/day and increased activity for alkaline phosphatase was observed in male rats at 600 mg/kg-bw/day. Both the observed effects are indicative of liver toxicity Reproductive performance:Inceased in pre-implantation losses were observed in 600 mg/kg-bw/day reated female rats as compared to control.Organ weights:Absolute and relative liver and adrenal weights were increased in male and female rats at 600 mg/kg-bw/day.Histopathology:Centrilobular hepatocyte enlargement of liver at 250 and 600 mg/kg-bw/day.Follicular cell hypertrophy of thyroid glands were observed in male rats at 600 mg/kg-bw/day.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yesDetails on embryotoxic / teratogenic effects:Mortality : Less offspring/litter were observed in 600 mg/kg bw/day treated group.Clinical signs : No treatment-related clinical signs of toxicity were observed in treatment groups.Body weight:No effect was observed on body weight of offsprings of treated female rats as compared to control.Gross pathology:No gross pathological abnormalities were observed in offsprings of treated female rats as compared to control.Nurobehaveral effect:Decreased completion of surface righting were observed in offsprings of 600 mg/kg bw/day treated female rats as compared to control.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: No effect on offsprings survival, clincal sign, body weigth, nurobehaveral effect and gross pathology was observed on F1 male/female test animal.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 250 mg /kg /day for F0 and F1 generation when Sprague-Dawley male and female rats were exposed to Benzenamine, N-phenyl-, styrenated.
- Executive summary:
In a combined repeate dose/reproductive/developmental toxicity screening test, Sprague-Dawleymale and female rats were exposed toBenzenamine, N-phenyl-, styrenated in the concentrations of 0, 50, 250 and 600 mg/kg bw/day orally by gavage. No effect were observed on survival, clinical sign, body weight, food consumption and water consumption of F0 treated rats as compared to control. However, changes were observed as decreased cholesterol levels in F0 male rats at 250 and 600 mg/kg bw/day and increased activity for alkaline phosphatase was observed in male rats at 600 mg/kg-bw/day. Similarly, less offspring/litter and higher percentage of pre-implantation losses were observed in 600 mg/kg bw/day treated group. No effect was observed on clinical sign and body weight of F1 offsprings. In addition, increased absolute and relative liver and adrenal weights were observed in F0 male and female rats at 600 mg/kg-bw/day. Centrilobular hepatocyte enlargement of liver at 250 and 600 mg/kg-bw/day and follicular cell hypertrophy of thyroid glands were observed in F0 male rats at600mg/kg-bw/day. Decreased completions of surface righting were observed in F1 offsprings of 600 mg/kg bw/day. Therefore, NOAEL was considered to be 250 mg /kg /day for F0 and F1 generation when Sprague-Dawley male and female rats were exposed to Benzenamine, N-phenyl-, styrenated orally by gavage for 53 days.
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