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EC number: 258-649-2 | CAS number: 53585-53-8
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of dibenzyltoluene on fetal developments of rats.
- Author:
- Kurosaki T, Kawashima K, Nakaura S, Tanaka S, Djajalaksana S and Takanaka A
- Year:
- 1 988
- Bibliographic source:
- Eisei Shikensho Hokoku 1988 ; 106 : 61-68.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- some information such as the purity or batch number of the test substance or concerning the exposure conditions are lacking.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dibenzylbenzene, ar-methyl derivative
- EC Number:
- 258-649-2
- EC Name:
- Dibenzylbenzene, ar-methyl derivative
- Cas Number:
- 53585-53-8
- Molecular formula:
- C21H20
- IUPAC Name:
- dibenzylbenzene, ar-methyl derivative
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 14 weeks for males and 12-13 weeks for females
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: individual aluminium cages for the gravid females
- Diet (e.g. ad libitum): solid diet (aliment MF, oriental yeast Co., Ltd.)
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 (6:00 to 18:00)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil (japanese pharmacopea)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: no data
VEHICLE
- Justification for use and choice of vehicle (if other than water): dibenzyltoluene is not soluble in water
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 2, 06 and 0.2 ml/kg, respectively for the dose-levels of 1000, 300 and 100 mg/kg/d
- Lot/batch no. (if required): no data
- Purity: no data - Details on analytical verification of doses or concentrations:
- No data
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: no data
- Length of cohabitation: one night
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 7 to day 17 of gestation
- Frequency of treatment:
- once a day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300 and 1000 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 20 dams
- Control animals:
- other: sesame oil
- Details on study design:
- - Dose selection rationale: The high-dose level was fixed according to preliminary assays showing a decrease in the body weight gain of gravid females given 1000 mg/kg/d of dibenzyltoluene.
Examinations
- Maternal examinations:
- CLINICAL OBSERVATION: daily
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION : Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/rat/day
WATER CONSUMPTION: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on 21 day of gestation
- Organs examined: no data - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of : Yes
- Number of dead and liv conceptuses : Yes - Fetal examinations:
- - External examinations: Yes (third per litter )
- Soft tissue examinations: Yes (third per litter ) after fixation for 2 weeks in Bouin's mixture according to the wilson's method
- Skeletal examinations: Yes (third per litter )
- Head examinations: Yes (third per litter )
- fetal weight: Yes - Statistics:
- - Implantation rate: Chi-square
- Weight of dams, food consumption, number of corpora lutea, number of implants, number of fetuses, fetal body weight: Student's t test (if homogeneous variance), Aspin-Welch t test (in other cases)
- Fetal mortality, sex ratio, abnormalities frequency: Wilcoxon test. - Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
CLINICAL FINDINGS:
Piloerection was observed in the highest dose group (1000 mg/kg/day).
MORTALITY:
Maternal mortality was not reported.
BODY WEIGHT:
A slight decrease in body weight gain was noted in dams exposed to 1000 mg/kg/day when compared to that of control.
FOOD CONSUMPTION:
A visible decrease in food intake was observed at 1000 mg/kg/day but no dose-related effect was found.
NECROPSY:
- Fertility parameters:
. All dams had live fetuses.
. A slight but statistically significant decrease in the number of corpora lutea was observed at 1000 mg/kg/day (274 corpora lutea in 20 pregnant females) when compared to control (299 corpora lutea) however since dibenzyltoluene was administered after the implantation should be performed (day 6), this effect was not considered to be treatment-related .
. Number of implants were unaffected by treatment and implant ratio was similar in all groups.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- (maternal toxicity)
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No teratogenic effects were found.
- Mortality:
. Fetal mortality was similar in treated and control groups.
- Litters examination:
. Litter sizes in all groups were similar.
. No significant difference in sex ratio was found.
. Pups body weight was nonetheless statistically reduced in the highest dose group when compared to control (3.8 vs 4.1 g in male, 3.6 vs 3.9 g in females).
. No toxicologically significant malformations were observed.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under these experimental conditions, the No-Observed-Adverse-Effect-Level (NOAEL) was 300 mg/kg/d for maternal toxicity and the No-Observed-Adverse-Effect-Level (NOAEL) was 1000 mg/kg/d for fetal toxicity.
- Executive summary:
The potential of Dibenzylbenzene, ar-methyl derivative to induce developmental toxicity after maternal exposure during the critical period of organogenesis was evaluated in rat according to a study design comparable to OECD Guideline N° 414.
Dibenzylbenzene, ar-methyl derivative was administered orally by gavage to three groups of 20 bred female Sprague-Dawley rats once daily from gestation days 7 through 17. Dosage levels were 0, 100, 300 and 1000 mg/kg/d.
Animals were observed daily for mortality and morbidity. Clinical observations, body weights and food consumption were recorded at appropriate intervals.
On gestation day 20, a hysterectomy was performed on each female. The uteri, placenta and ovaries were examined, and the number of foetuses, resorptions, total implantations, and corpora lutea were recorded. Gravid uterine weights were recorded. The foetuses were weighted, sexed and examined for external, visceral and skeletal malformations and developmental variations.
All animals survived to the scheduled necropsy. Piloerection was observed in females given 1000 mg/kg/d as well as a slight decrease in body weight gain and food consumption.
The slight increase in the resorption of corpora lutea noted in the highest dose group was not considered as relevant since the administration of Dibenzylbenzene, ar-methyl derivative occurred after the implantation. The survival of the pups was unaffected by Dibenzylbenzene, ar-methyl derivative administration at all dose levels. However, pups body weight was reduced in the highest dose group when compared to controls but this effect was related to the maternal toxicity observed. Foetal external, soft tissue and skeletal malformations observed in control and treated pups were considered to be spontaneous in origin. The developmental variations expressed in the treated groups were generally similar to those present in the control group or occurred in a manner that was not dose related.
Under these experimental conditions, the No-Observed-Adverse-Effect-Level (NOAEL) was 300 mg/kg/d for maternal toxicity and the No-Observed-Adverse-Effect-Level (NOAEL) was 1000 mg/kg/d for fetal toxicity.
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