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EC number: 202-336-5 | CAS number: 94-47-3
- 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:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from a secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Teratological Studies on the test chemical in Pregnant Rats.
- Author:
- Ishiguro et al
- Year:
- 1 993
- Bibliographic source:
- Kagoshima Univ, 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Equivalent or similar to OECD Guideline 414 (Pre-Natal Developmental Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Benzyl acetate
- EC Number:
- 205-399-7
- EC Name:
- Benzyl acetate
- Cas Number:
- 140-11-4
- Molecular formula:
- C9H10O2
- IUPAC Name:
- Acetic acid, phenylmethyl ester
- Test material form:
- not specified
- Details on test material:
- Name: Benzyl acetate
CAS No.: 140-11-4
Molecular Formula: C9-H10-O2
Molecular Weight: 150.176
SMILES: c1(COC(C)=O)ccccc1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No Data Available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with olive oil to achieve concentration levels of 1000, 500, 100, 10 and 0 mg/ml
VEHICLE
- Justification for use and choice of vehicle (if other than water): olive oil
- Concentration in vehicle: Not documented
- Amount of vehicle (if gavage): Not documented
- Lot/batch no. (if required): VDR7446
- Purity: Not documented - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available.
- Details on mating procedure:
- On confirmation of the oestrous cycle of the females, 12-17 week old male rats were introduced and the males and females were co-housed from 5pm until the next morning when the presence of sperm in the vagina was considered to be successful mating. This was considered to be day zero of pregnancy. Based on their weight, pregnant rats were separated into 6 groups and relocated to separate cages.
- Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily from gestation day 6 to 15
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 100, 500, 1000 mg/kg bw/day
- No. of animals per sex per dose:
- 20 rats/dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No Data Available
Examinations
- Maternal examinations:
- Parent examinations
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Every 2 days
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, examined every 2 days.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
POST-MORTEM EXAMINATIONS: Yes - Sacrifice on gestation day 20
- Organs examined: No Data Available
OTHER: The implantation in the womb, corpus lutea quantity, the implantation quantity, the resorption embryo count and the living or dead foetuses. The weight of the placenta was measured.
Ovaries and uterine content:The ovaries and uterine content was examined after termination.
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes - Number of early resorptions: No data - Number of late resorptions: No data - Other:
Fetal examinations
- External examinations: Yes: all living foetuses - Soft tissue examinations: Yes: half per litter - Skeletal examinations: Yes: - Head examinations: No data
Statistics
One way layout dispersion method if equal dispersion detected. The Kruskal-Wallis method was used to verify significance in the case of equal dispersion. The multi-comparison verification method of Scheffe and Dunnett was used to verify the significance of subjected groups. An X2 verification method was also performed to determine the frequency of of the bone changes, internal organs of the foetuses and the gender comparison of the surviving foetuses. - Ovaries and uterine content:
- Yes. The number of implantation and corpora lutea, live/dead fetuses, resorptions, implantation ratio, sex ratio, or placenta weigh were recorded.
- Fetal examinations:
- Yes, on GD 20th foetuses were examined for intrauterine death, and internal, external and skeletal malformations.
- Statistics:
- Yes. Results were analyzed using Bartlett's test, test method of Kruskal-Wallis, Dunnett's multiple comparison testing method or Scheffe's multiple comparison testing method.
- Indices:
- No data available.
- Historical control data:
- No data available.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of toxicity were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- A slightly decreasing in maternal body weight gain was noted in the 1,000 mg/kg group, but not significantly.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption did not differ between treated and control groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment related adverse effect was observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related adverse effect was observed.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- The number of implantations did not differ in treated and control rats.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- The number of resorptions did not differ in treated and control rats.
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- The number of resorptions did not differ in treated and control rats.
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- The number of live/dead fetuses did not differ in treated and control rats.
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- The placenta weight did not differ in treated and control rats.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Maternal general toxicity
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- mortality
- organ weights and organ / body weight ratios
- Dose descriptor:
- NOAEL
- Remarks:
- Maternal developmental
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- dead fetuses
- early or late resorptions
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- other: No maternal developmental toxicity was observed.
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The fetal body weight was significantly decreased at 1000 mg/kg, but significantly increased at 10 and 100 mg/kg.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- The number of live/dead fetuses were comparable in treated and control groups.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratio of fetuses was comparable in treated and control groups.
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- No increase in incidence of external malformations were seen at any dose level.
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- The only skeletal malformation (fused ribs) was seen in one foetus of the high-dose group, which did not increase the incidence of skeletal malformations compared to controls. The authors suggested that the skeletal malformations were related to the significant decrease in fetal body weight. Skeletal variations (i.e., wavy ribs, dumbbell shaped vertebrae, absence/splitting of thoracic vertebrae, presence of lumbar ribs and degree of ossification) were statistically increased at 1000 mg/kg.
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a statistically significant increase in the combined incidence of organ variations (i.e., slight dilatation of the lateral ventricle and renal pelvis, and presence of levo-umbilical artery) in animals from the 500 and 1000 mg/kg dose groups.
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Remarks:
- Developmental
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
- Remarks on result:
- other: No adverse developmental effect was observed.
Applicant's summary and conclusion
- Conclusions:
- The oral administration of the test chemical up to 1000 mg/kg was not maternally toxic as no adverse effect on parameters examined were observed. The prenatal exposure to 1000 mg/kg of the test chemical substance did not alter the normal growth and development of offspring and, consequently the developmental NOAEL was 1000 mg/kg for both maternal and F1 generations.
- Executive summary:
A prenatal developmental toxicity study was performed to investigate the toxic effect of the test chemical on fetus organogenesis and development. Groups of 20 pregnant Wistar rats were administered 0, 10, 100, 500, or 1,000 mg/kg bw/day by gavage during gestation days 6-15 (GD 6-15). On day 20 of gestation, pregnancies were terminated, and the fetuses were examined for intrauterine death, and internal, external and skeletal malformations. Maternal parameters included mortality, body weight, food consumption, and clinical and gross examinations. No maternal toxic effects on parameters examined were observed as no death and alterations of body weight, food consumption was reported, and clinical and gross examinations did not reveal any effect attributable to test chemical administration. Examination of the uterus content revealed that the number of implantation and corpora lutea, live/dead fetuses, or resorptions, implantation ratio, sex ratio, or placenta weigh did not differ in treated and control rats.The fetal body weight was significantly decreased at 1000 mg/kg and significantly increased at low and middle doses, thus these alterations were inconclusive and showed no dose-dependence.There was a statistically significant increase in the combined incidence of organ variations (i.e., slight dilatation of the lateral ventricle and renal pelvis, and presence of levo-umbilical artery) in animals from the 500 and 1000 mg/kg dose groups. The only skeletal malformation (fused ribs) was seen in one fetus of the high-dose group, which did not increase the incidence of skeletal malformations compared to controls. The authors suggested that the skeletal malformations were related to the significant decrease in fetal body weight. Skeletal variations (i.e., wavy ribs, dumbbell shaped vertebrae, absence/splitting of thoracic vertebrae, presence of lumbar ribs and degree of ossification) were statistically increased at 1000 mg/kg. However, skeletal variations are minor structural changes which have little or no detrimental effect on the animal and often are transient changes. No increase in intrauterine death or external variations was noted at any dose level.In conclusion, the oral administration of the test chemical up to 1000 mg/kg was not maternally toxic evidenced by the absence of alterations of parameters examined. In addition, the prenatal exposure to 1000 mg/kg of the test substance did not alter the normal growth and development of offspring and, consequently the developmental NOAEL was 1000 mg/kg for the F1 generation.
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