Registration Dossier
Registration Dossier
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EC number: 203-013-1 | CAS number: 102-20-5
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- chronic toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity
- Author:
- E. C. Hagan, W. H. Hansen, O. G. Fitzhugh, P. M. Jenner, W. I. Jones, Jean M. Taylor, Eleanor L. Long, A. A. Nelson and J. B. Brouwer
- Year:
- 1 967
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol 5, pp. 141-157. 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Reproductive toxicity study of test chemical was performed on Osborne-Mendel rats.
- GLP compliance:
- not specified
- Limit test:
- yes
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Phenethyl phenylacetate
- EC Number:
- 203-013-1
- EC Name:
- Phenethyl phenylacetate
- Cas Number:
- 102-20-5
- Molecular formula:
- C16H16O2
- IUPAC Name:
- 2-phenylethyl phenylacetate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Phenethyl phenylacetate
- IUPAC Name: 2-phenylethyl 2-phenylacetate
- Molecular formula : C16H16O2
- Molecular weight : 240.30 g/mole
- Inchi: 1S/C16H16O2/c17-16(13-15-9-5-2-6-10-15)18-12-11-14-7-3-1-4-8-14/h1-10H,11-13H2
- Smilies notation:c1(CC(OCCc2ccccc2)=O)ccccc1
- Substance type: Organic
- Physical state: Colorless Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:The animals were housed individually in wire cages
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: test material soluble in corn oil.
DIET PREPARATION
- Rate of preparation of diet (frequency):Fresh diets were made and distributed weekly
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil
- Concentration in vehicle: 0,500 mg/kg bw/day
- Amount of vehicle (if gavage): 1ml of solution/kg daily
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Total:40
0 mg/kg bw/day: 10 male and 10 female
500.00 mg/kg bw/day: 10 male and 10female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: every week.
BODY WEIGHT: Yes
Time schedule for examinations: every week.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was determined every week.
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- SACRIFICE:At the termination of the experiments the rats were sacrificed and exsanguinated.
- Gross necropsy : yes
HISTOPATHOLOGY / ORGAN WEIGHTS: The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera
were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Tissues from rats dying during the experiment were examined for gross changes and were preserved if autolysis was not advanced. Organs were not weighed but abnormalities and the suspected reason for death were noted. - Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- No effects on reproductive organ weight
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effects on reproductive organ was noted
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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
- Sexual maturation:
- not specified
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to 500mg/kg/day, When male and female Osborne-Mendel rats were treated with test chemical orally for 17weeks.
- Executive summary:
The reproductive toxicity of the test chemical was considered on the basis of repeated dose toxicity study.Groups of 10 male and 10 female Osbourne-Mendel rats were provided test chemical mixed in the diet at concentrations of 0, 1000, 2500 or 10,000 ppm which corresponding to an average daily intakes of 0, 50, 250, or 500 mg/kg bw per for 17 weeks. The animal’s weight, food intake and general condition were recorded every week. Haematological examinations were made at termination of the subacute studies. These examinations included white cell counts, red cell counts, haemoglobins and haematocrits. At the termination of the experiments the rats were sacrificed and exsanguinated. The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Measurement of body weight and food intake recorded weekly showed no significant difference between test and control animals at any intake level. At termination, hematological examinations revealed no effects due to administration of the test chemical. At necropsy, no differences were reported in major organ weights between test and control animals. Gross examination of tissue of all animals was unremarkable and histopathological examination of six-eight animals, equally represented by gender, for the high-dose group and the control group revealed no treatment-related lesions. Hence, the highest dose tested i.e 500 mg/kg/day can be considered as the NOAEL
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