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EC number: 204-559-3 | CAS number: 122-63-4
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SCREENING-LEVEL HAZARD CHARACTERIZATION Benzyl Derivatives Category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 010
- Bibliographic source:
- U.S. Environmental Protection Agency Hazard Characterization Document, September, 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Developmental toxicity study of benzyl acetate was performed in Pregnant Wistar rats via oral gavage.
- GLP compliance:
- not specified
- Limit test:
- no
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:
- benzyl acetate
- Details on test material:
- - Name of test material: Benzyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.17 g/mol
- Substance type: Organic
- Physical state: Liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Benzyl acetate
- Molecular formula: C9H10O2
- Molecular weight: 150.17 g/mol
- Substance type: Organic
- Physical state: Liquid
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No data
- Duration of treatment / exposure:
- 10 days (GD 6-15)
- Frequency of treatment:
- Daily
- Duration of test:
- Upto gestation days 20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 100, 500 or 1000 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- 20 per dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- No data
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations:
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes / No / No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes / No / No data
- Sacrifice on gestation day #
- Organs examined:
OTHER: - Ovaries and uterine content:
- No data
- Fetal examinations:
- fetuses were examined for intrauterine death and internal, external and skeletal changes.
- Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
There were no indications of maternal toxicity in any dose group.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No toxic effects observed
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: Developmental effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Maternal abnormalities
- Abnormalities:
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Fetal body weight was significantly decreased (p < 0.05) at 1000 mg/kg/day. - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- effects observed, treatment-related
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- the 1000mg/kg bw dose group exhibited increased skeletal variations including wavy ribs, dumb-bell shaped vertebrae, absence/splitting of thoracic vertebrae, presence of lumbar ribs and degree of ossification
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Fetuses at 500 and 1000 mg/kg/day exhibited increased combined incidence of organ variations (slight dilatation of the lateral ventricle and renal pelvis and presence of levo-umbilical artery)
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Fetal body weight was significantly decreased (p < 0.05) at 1000 mg/kg/day. Fetuses at 500 and 1000 mg/kg/day exhibited increased combined incidence of organ variations (slight dilatation of the lateral ventricle and renal pelvis and presence of levo-umbilical artery) and the high-dose group exhibited increased skeletal variations including wavy ribs, dumb-bell shaped vertebrae, absence/splitting of thoracic vertebrae, presence of lumbar ribs and degree of ossification
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: overall developmental effects
- Remarks on result:
- other: overall developmental effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL value of benzyl acetate is considered to be 1000 mg/kg/day for maternal toxicity and 100 mg/kg/day for developmental toxicity whereas the LOAEL value for developmental toxicity is considered to be 500 mg/kg/day based on increased combined incidence of organ and skeletal variations. When Pregnant Wistar rats were treated with benzyl acetate (140-11-4) orally.
- Executive summary:
In developmental toxicity study of benzyl acetate (140-11-4) was performed in Pregnant Wistar rats. The test material in dose concentration 0, 10, 100, 500 or 1000 mg/kg/day was administered via gavage for 10 days (GD 6-15).20 animals in each dose group were used. All the animals were observed Up to gestation days 20. fetuses were examined for intrauterine death and internal, external and skeletal changes. There were no indications of maternal toxicity in any dose group. Fetal body weight was significantly decreased (p < 0.05) at 1000 mg/kg/day. Fetuses at 500 and 1000 mg/kg/day exhibited increased combined incidence of organ variations (slight dilatation of the lateral ventricle and renal pelvis and presence of levo-umbilical artery) and the high-dose group exhibited increased skeletal variations including wavy ribs, dumb-bell shaped vertebrae, absence/splitting of thoracic vertebrae, presence of lumbar ribs and degree of ossification. Hence The NOAEL value of benzyl acetate is considered to be 1000 mg/kg/day for maternal toxicity and 100 mg/kg/day for developmental toxicity whereas the LOAEL value for developmental toxicity is considered to be 500 mg/kg/day based on increased combined incidence of organ and skeletal variations. When Pregnant Wistar rats were treated with benzyl acetate (140-11-4) orally.
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