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Diss Factsheets
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EC number: 202-311-9 | CAS number: 94-18-8
- 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
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Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- The estrogenic effects of benzylparaben at low doses based on uterotrophic assay in immature SD rats
- Author:
- Ying Hu , Zhaobin Zhang , Libei Sun , Desheng Zhu , Qingchun Liu , Jian Jiao , Jun Li , Mingwen Qi
- Year:
- 2 013
- Bibliographic source:
- Food and Chemical Toxicology 53 (2013) 69–74
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as per mentioned below
- Principles of method if other than guideline:
- Study of estrogenic effects on the basis of uterotrophic assay in immature SD rats treated with benzylparaben.
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzyl 4-hydroxybenzoate
- EC Number:
- 202-311-9
- EC Name:
- Benzyl 4-hydroxybenzoate
- Cas Number:
- 94-18-8
- Molecular formula:
- C14H12O3
- IUPAC Name:
- benzyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Benzylparaben (Synonyms of Benzoic acid, 4-hydroxy-, phenyl methyl ester)
- Molecular formula (if other than submission substance): C14-H12-O3
- Molecular weight (if other than submission substance): 228.2458 g/mol
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): Purity: >98%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Experimental Animal Tech Co. of Weitonglihua (Beijing, China).
- Age at study initiation: Immature SD rats (Post natal day :20)
- Weight at study initiation: 61.1 ± 7.9 to 68.5 ± 6.3g
- Fasting period before study: No data available
- Housing: two or three rats per stainless steel wire-mesh cage
- Diet (e.g. ad libitum): basic diet (ad libitum)
- Water (e.g. ad libitum): sufficient drinking water (ad libitum)
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- other: Oral (Intragastric administration)
- Vehicle:
- peanut oil
- Details on oral exposure:
- Details on oral exposure
PREPARATION OF DOSING SOLUTIONS: No data available
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 available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: No data available
- 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
- Duration of treatment / exposure:
- 3 days (PND 21 -24)
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.16, 0.8, 4, 20, and 100 mg/kg bw/day for experiment 1 0.0064 and 0.032 mg/kg bw/ day for experiment 2
Basis:
no data
- No. of animals per sex per dose:
- 14 /dose
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. No data available
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: daily
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: No data available
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER:
Uterotrophic assay: Performed on PND 24 day, uterus of each rat was dissected. Each uterus was blotted, and the blotted weight was recorded. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data available
- Statistics:
- One-way analysis of variance and Fisher’s least significant difference (LSD) method.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Mortality: All rats were scarified at PND 24 day after 24 hrs of last treated diet taken. Clinical signs: No data available
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality: All rats were scarified at PND 24 day after 24 hrs of last treated diet taken. Clinical signs: No data available
- 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
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Uterus weight was increased of rats given 0.16 mg/kg/day or more of benzylparaben. The relative uterine weight was increased to 103%, 107%, 119%, 124%, 127%, 131%, and 136% that of rats in the control group.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Uterine weight was increased
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Effect levels
- Dose descriptor:
- other: LOED (Lowest observed Effective dose)
- Effect level:
- 0.16 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Blotted Uterus weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The endpoint for repeated dose toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
- Executive summary:
Repeated dose toxicity test was performed on SD rats from PND 21 to PND 24 days were treated with benzylparaben. The chemical was given by Intragastric route dissolve in peanut oil. On 24 PND days the rats were scarified by chloroform anesthesia 24 h after the final treatment. The uterus of all rats were dissected and blotted to study the uterotrophic effect of benzylparaben. Relative uterine weight was calculated for each animal.
After experiment it was found that the relative uterine weight was increased to 103%, 107%, 119%, 124%, 127%, 131%, and 136% that of rats in the control group.
Therefore, the endpoint for repeated dose toxicity test for benzylparaben (94-18-8) was found to be LOED at 0.16 mg/kg/day.
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