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EC number: 421-090-1 | CAS number: 131298-44-7
- 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
- Study period:
- 04 August 1994 to 10 February 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was audited by the Wil Quality Assurance Unit throughout the progression of events and determined to have been conducted in compliance with the United States Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) Good Laboratory Practice Regulations (40 CFR Part 792), August 17, 1989, and Health Effects Testing Guidelines for Developmental Toxicity Studies (40 CFR Part 798.4900), May 20, 1987, and the Standard Operating Procedures of WIL Research Laboratories, Inc. The study was conducted in accordance with the protocol and protocol amendments as approved by the sponsor and assured by the QA Unit that the final report accurately describes the conduct and findings of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4900 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 131298-44-7
- EC Number:
- 603-470-0
- Cas Number:
- 131298-44-7
- IUPAC Name:
- 131298-44-7
- Reference substance name:
- Benzoic acid, C9-11, C10-rich branched alkyl esters
- IUPAC Name:
- Benzoic acid, C9-11, C10-rich branched alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): Isodecyl Benzoate
- Physical state: Liquid, Clear colorless
- Analytical purity: Considered to be 100% Isodecyl Benzoate
- Lot/batch No.: Batch C5-8, 5/15/94
- Stability under test conditions: Considered stable at room temperature
- Storage condition of test material: Dose preparations tested to be stable for 8 days under refridgeration.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®BR
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan
- Age at study initiation: approximately 12 weeks old when paired for breeding
- Weight at study initiation: a minimum of 220 g at breeding (220 g to 279 g on day 0 of gestation)
- Fasting period before study: none
- Housing: clean, wire-mesh cages suspended above cage-board
- Diet (e.g. ad libitum):ad libitum, Purina® Certified Rodent Chow® #5002
- Water (e.g. ad libitum):ad libitum, Municipal water delivered by an automatic watering system
- Acclimation period:12 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65° to 71 °F
- Humidity (%): 58% to 82%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12 hrs dark / 12 hrs light
IN-LIFE DATES: From:08-23-1994 To:09-16-1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- The selected route of administration was oral because this is the anticipated route of exposure for the general human population. The animal model was selected based on the availability of historical control data and the susceptibility of the species to known developmental toxicants.
PREPARATION OF DOSING SOLUTIONS:An appropriate amount of the vehicle, Ma.zola® corn oil, was dispensed into a properly-labeled storage container for administration to the control group.
An appropriate amount of the test material, Isodecyl Benzoate, was weighed for each group into tared, precalibrated storage containers. A sufficient amount of the vehicle, Mazola® corn oil, was added to bring the volume to the calibration mark. The preparations were placed on the Polytron® PT 6000 laboratory mixer for approximately 5 minutes. A stir bar was added, and the dosing suspensions were stirred on a magnetic stir plate throughout the sampling and dosing procedures. Preparations for all dose groups were formulated three times (August 26, September 2, and September 9, 1994) and were stored refrigerated.
Individual dosages were based on the most recently recorded body weight to provide the correct mg/kg/day dose.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Ma.zola® corn oil was a common supension vehicle for gavage
- Concentration in vehicle: 0, 6, 60, and 200 mg/ml (0, 30, 300, and 1000 mg/kg/day dosage)
- Amount of vehicle (if gavage): A dosage volume of 5 ml/kg was used for all dosage levels.
- Lot/batch no. (if required): NA - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The dosing preparations were analized on three occasions by gaschromatography/flame ionization detection (FID) with splitless injection. Mean analyzed concentrations were between 97.3% and 107% of the target dose concentrations
- Details on mating procedure:
- - Impregnation procedure:cohoused
- M/F ratio per cage: 1:1
- Length of cohabitation: Not Identified
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol:No - Duration of treatment / exposure:
- Gestation days 6-15
- Frequency of treatment:
- Once daily
- Duration of test:
- Laparohysterectomies performed on Gestation Day 20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Concentration in vehicle: 0, 6, 60, and 200 mg/ml (0, 30, 300, and 1000 mg/kg/day dosage). A dosage volume of 5 ml/kg was used for all dosage levels.
Basis:
analytical conc.
- No. of animals per sex per dose:
- 25 mated females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels were selected based on the results of a dosage range-finding developmental toxicity study of Isodecyl Benzoate in rats (WIL-152 17).
- Rationale for animal assignment:The bred females were consecutively assigned in a block design to groups containing 25 rats each by the following randomization procedure. The first mated female and the appropriate gestation day 0 designation were recorded, and the female was assigned to group 1, the second mated female was assigned to group 2, and the third to group 3, etc. This process was continued daily until 25 females were placed into each group.
All maternal animals were euthanized by carbon dioxide inhalation on gestation day 20. The thoracic, abdominal and pelvic cavities were opened by a ventral mid-line incision, and the contents were examined. In all instances, the post mortem findings were correlated with the ante mortem comments and any abnormalities were recorded. The uterus and ovaries were excised, and the number of corpora lutea on each ovary was recorded. The trimmed uterus was weighed and opened, and the number and location of all fetuses, early and late resorptions and the total number of implantation sites were recorded. The individual uterine distribution of implantation sites was documented using the following procedure. All implantation sites, including resorptions, were numbered in consecutive order beginning with the left distal to the left proximal uterine horn, noting the position of the cervix, and continuing from the right proximal to the right distal uterine horn. Maternal tissues were preserved in 10% neutral buffered formalin for possible future histopathological examination only as indicated by the gross findings. The carcass of each dam was then discarded.
Uteri with no macroscopic evidence of nidation were excised, opened and subsequently placed in 10% ammonium sulfide solution for detection of early implantation loss as described by Salewski3.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily for moribundity and mortality
- Cage side observations checked were included in report Summary Tables 1, 2, and 3; Individual Data in Tables 17 and 18.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Detailed clinical observations were recorded individually from days 0 through 20 of gestation. Observations were recorded before dosing during the dosing period. Animals were also observed for signs of toxicity approximately one hour following treatment throughout the dosing period. All significant findings were recorded at the post-dosing observation periods.
BODY WEIGHT: Yes
- Time schedule for examinations: Individual maternal body weights were recorded on gestation days 0, 6-16 and 20. A group mean body weight was calculated for each of these days. Mean body weight changes were calculated for each corresponding interval and also for days 6-9, 9-12, 12-16, 6-16 and 0-20.
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes-Individual food consumption was recorded on gestation days 0, 6, 9, 12, 16 and 20. Food intake was reported as g/animal/day and g/kg/day for each corresponding body weight change interval
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: Gross examination of abdominal organs
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes- Gravd uterine weight was collected and net body weight (the day 20 body weight minus the weight of the uterus and contents) and net body weight change (the day 0-20 body weight change minus the weight of the uterus and contents) were calculated and presented for each gravid female at the scheduled laparohysterectomy.
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other :Maternal tissues were preserved in 10% neutral buffered formalin for possible future histopathological examination only as indicated by the gross findings. - Fetal examinations:
- - External examinations: Yes: [all per litter ]
- Soft tissue examinations: Yes: [all per litter ] Each fetus was examined viscerally by a modification of the Stuckhardt and Poppe fresh dissection technique to include the heart and major vessels. The sex of each fetus was verified by an internal examination. Fetal kidneys were examined and graded for renal papillae development by a method described by Woo and Hoai.
- Skeletal examinations: Yes: [all per litter] All carcasses were eviscerated and fixed in 100% ethyl alcohol. Following fixation in alcohol, each fetus was macerated in potassium hydroxide and stained with Alizarin Red S by a method similar to that described in Dawson. The skeletal examination was conducted using low power magnification provided by a stereomicroscope. External, visceral and skeletal findings were recorded as developmental variations or malformations.
- Head examinations: Yes: [half per litter] Heads were placed in Bouin’s fixative for subsequent soft-tissue examination by the Wilson sectioning technique. The heads from the remaining one-half of the fetuses were examined by a mid-coronal slice. - Statistics:
- All analyses were conducted using two-tailed tests for a minimum significance level of 5% comparing each treated group to the vehicle control group. Each mean was presented with the standard deviation (S.D.) and the number of animals (N) used to calculate the mean. The following statistical tests were performed by a DigitaP MicroVAX® 3400 computer (with appropriate programming) in this laboratory and are referenced on the report tables:
Fetal Sex Ratios (Chi-square test with Yates’ correction factor), Malformations and Variations (Fisher’s Exact test), Early and Late Resorptions, Dead Fetuses, Postimplantation Losses, Mean Litter Proportions of Malformations and Variations (Mann-Whitney U-test), Corpora Lutea, Total Implantations, Viable Fetuses, Fetal Body Weights, Maternal Body Weights and Weight Changes, Maternal Net Body Weight Changes, Gravid Uterine Weights, Maternal Food Consumption (One-way ANOVA with Dunnett’s test), Litter Proportions of Intrauterine Data (Considering the Litter, rather than the Fetus, as the Experimental Unit) (Kruskal-Wallis test). - Indices:
- The fetal developmental findings were summarized by: 1) presenting the incidence of a given finding both as a percentage of the number of fetuses and the number of litters available for examination in the group; and 2) considering the litter as the basic unit for comparison and calculating the number of affected fetuses in a litter on a proportional basis.
- Historical control data:
- Tables of WIL Laboratories Historical Control data for Sprague-Dawley Crl:CD’BR Rats (Summary Values) and data for Sprague-Dawley Crl:CD®BR Rats (Individual Values) are included in the Report Appendicies B and C, respectively.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
A mean body weight loss occurred in the 1000 mg/kg/day group during gestation days 6-9. Food consumption was unaffected at all dose levels.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day (actual dose received)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
The only adverse effects of treatment on the developing fetus were a decrease in the mean fetal body weight and a reduction in the incidence of cervical centrum no. 1 ossified (both of which are indications of developmental retardation in the fetuses) in the 1000 mg/kg/day group.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
All maternal animals survived to the scheduled necropsy; no clinical signs related to compound administration were noted in the treated groups. A mean body weight loss occurred in the 1000 mg/kg/day group during gestation days 6-9. Food consumption was unaffected by treatment throughout the study period in all dose groups. No treatment-related internal findings were observed at necropsy. The only adverse effects of treatment on the developing fetus were a decrease in the mean fetal body weight and a reduction in the incidence of cervical centrum no. 1 ossified (both of which are indications of developmental retardation in the fetuses) in the 1000 mg/kg/day group. No other treatment-related malformations or developmental variations were observed at any dose level.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, maternal toxicity was exhibited at a dose level of 1000 mg/kg/day by a transient mean body weight loss. Developmental toxicity was exhibited at a dose level of 1000 mg/kg/day by a slight decrease in mean fetal body weight and a reduction in the incidence of cervical centrum no.1 ossified. Based on the results of this study, a dose level of 300 mg/kg/day was considered to be the NOAEL (no observable adverse effect level) for maternal toxicity and developmental toxicity.
- Executive summary:
The potential maternal toxicity and developmental toxicity of Isodecyl Benzoate were evaluated. Isodecyl Benzoate in Mazola® corn oil was administered orally by gavage to three groups of 25 bred Sprague-Dawley Crl:CJYBR female rats once daily from gestation days 6 through 15. Dosage levels were 30, 300 and 1000 mg/kg/day administered at a dose volume of 5 mllkg. A concurrent control group composed of 25 bred females received the vehicle, Mazola® corn oil, on a comparable regimen at 5 mllkg. All rats were observed twice daily for appearance and behavior. Body weights and food consumption were recorded at appropriate intervals. A laparohysterectomy was performed on all animals on gestation day 20. The uteri and ovaries were examined and the numbers of fetuses, early and late resorptions, total implantations and corpora lutea were recorded. Mean gravid uterine weights and net body weight changes were calculated for each group. The fetuses were weighed, sexed and examined for external, soft tissue and skeletal malformations and developmental variations.
All maternal animals survived to the scheduled necropsy; no clinical signs related to compound administration were noted in the treated groups. A mean body weight loss occurred in the 1000 mg/kg/day group during gestation days 6-9. Food consumption was unaffected by treatment throughout the study period in all dose groups. No treatment-related internal findings were observed at necropsy. The only adverse effects of treatment on the developing fetus were a decrease in the mean fetal body weight and a reduction in the incidence of cervical centrum no. 1 ossified (both of which are indications of developmental retardation in the fetuses) in the 1000 mg/kg/day group. No other treatment-related malformations or developmental variations were observed at any dose level.
In conclusion, maternal toxicity was exhibited at a dose level of 1000 mg/kg/day by a transient mean body weight loss. Developmental toxicity was exhibited at a dose level of 1000 mg/kg/day by a slight decrease in mean fetal body weight and a reduction in the incidence of cervical centrum no.1 ossified. Based on the results of this study,a dose level of 300 mg/kg/day was considered to be the NOAEL (no observable adverse effect level) for maternal toxicity and developmental toxicity.
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