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EC number: 271-091-4 | CAS number: 68515-49-1
- 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
Endocrine disrupter mammalian screening – in vivo (level 3)
Administrative data
- Endpoint:
- endocrine disrupter mammalian screening – in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The antiandrogenic effects of phthalate, di-isodecyl phthalate (DIDP) was investigated by Hershberger assay in castrated male SD rats. An androgen agonist, testosterone (0.4 mg/kg/d), was administered for 10 consecutive days by subcutaneous (sc) injection as a positive control. DIDP was administered at 20, 100, or 500 mg/kg body weight (bw)/d orally in combination with testosterone (0.4 mg/kg/d, sc) for 10 consecutive days, respectively.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- EC Number:
- 271-091-4
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich
- Cas Number:
- 68515-49-1
- Molecular formula:
- C28 H46 O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10 rich
- Test material form:
- liquid
- Details on test material:
- CAS number: 68515-49-1
EC number 271-091-4
Constituent 1
- Specific details on test material used for the study:
- Expiration Date: Not specified
Purity: Not specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Crl:CD
- Sex:
- male
- State:
- castrated male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Samtako Inc. (Osan, Korea)
- Age at study initiation: 4 wk old
- Weight at study initiation: 185 ± 10 g
- Housing: Housed under specific pathogen-free (SPF) conditions
- Diet (e.g. ad libitum): Pelleted rodent diet available ad libitum
- Water (e.g. ad libitum): Drinking water available ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3°C
- Humidity (%): 55 ± 5%
- Air changes (per hr): 10–18 times per hour
- Photoperiod (hrs dark / hrs light): illuminated artificially for 12 h daily at 300–500 lux.
The procedure used for castration was based on the Organization for Economic Cooperation and Development (OECD) protocol for detecting endocrine disruptors (OECD, 2001). Castration (removal of testis and epididymis) was performed on 6-wk-old animals weighing 215 ± 16 g via a midline incision, and treatment with test compounds was commenced 1 wk later to allow the animals time for to recover completely.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- DIDP was dissolved in corn oil and administered at 20, 100, or 500 mg/kg bw/d to testosterone propionate (TP)-treated (0.4 mg/kg bw/d) castrated rats by oral gavage until d 10.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- DIDP was administered at 20, 100, or 500 mg/kg bw/d to testosterone propionate (TP)-treated (0.4 g/kg bw/d) castrated rats by oral gavage until d 10.
- Frequency of treatment:
- DIDP was administered daily for 10 consecutive days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 20 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Details on study design:
- The test substance DIDP was administered at 20, 100, or 500 mg/kg bw/d to testosterone propionate (TP)-treated (0.4 mg/kg bw/d) castrated rats by oral gavage until gestation day 10. Through the experimental period, the animals were observed at least once a day, and body weights and abnormalities were recorded daily. All animals in each group underwent autopsy at the end of experiment. Vital organs including liver, kidneys, and adrenal glands and the following sex accessory tissues were dissected and weighed; testes, ventral prostates, combined seminal vesicles and coagulating glands, levator ani/bulbocavernosus (LABC), and Cowper’s glands.
- Positive control:
- An androgen agonist, testosterone (0.4 mg/kg/d), was administered for 10 consecutive days by subcutaneous (sc) injection as a positive control.
Examinations
- Observations and examinations performed and frequency:
- Through the experimental period, the animals were observed at least once a day, and body weights and abnormalities were recorded daily.
- Sacrifice and pathology:
- All animals in each group underwent autopsy at the end of experiment. Vital organs including liver, kidneys, and adrenal glands and the following sex accessory tissues were dissected and weighed; testes, ventral prostates, combined seminal vesicles and coagulating glands, levator ani/bulbocavernosus (LABC), and Cowper’s glands.
- Other examinations:
- Hormone Analysis: Blood was collected by exsanguination following ether anesthesia from the abdominal aorta and serum was prepared and stored at -80°C for hormone determinations.
Commercially available radioimmunoassay (RIA) kits were used to measure the serum concentrations of testosterone and luteinizing hormone (LH) (Amersham Corp., Arlington Heights, IL). - Statistics:
- All values are expressed as means ± SD. Quantitative differences between nontreated control groups and treated animal groups in terms of body and organ weights were analyzed by one-way analysis of variance (ANOVA). Dunnett’s test (significance criterion set at p < .05) was used for pairwise comparisons between control groups and treatment groups.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increases in liver weights were observed at the highest doses (500 mg/kg/d) of DIDP, compared with testosterone treatment alone.
Ventral prostate and seminal vesicles weights were significantly reduced by DIDP at 500 mg/kg/d. - Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
Effect levels
- Key result
- Dose descriptor:
- dose level:
- Effect level:
- >= 500 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- organ weights
Any other information on results incl. tables
Table 1
Antiandrogenic Effects: Hershberger Assay Response to Phthalates in Castrated Male Rats After 10 d of Treatment
Experimental compoundsa and dose (mg/kg) | Initial b.w. (g) | Final b.w. (g) | Liver (g) | Kidneys (g) | Adrenals (g) |
Conb | 174.7 ± 9.7 | 207.3 ± 10.5 | 8.28 ± 0.69 | 1.42 ± 0.11 | 42.4 ± 3.6 |
Tc | 176.5 ± 11.5 | 211.8 ± 18.0 | 8.47 ± 1.13 | 1.67 ± 0.12 | 45.9 ± 5.7 |
DIDP |
|
|
|
|
|
20 | 176.2 ± 8.9 | 216.4 ± 14.7 | 8.62 ± 0.52 | 1.60 ± 0.02 | 46.2 ± 2.5 |
100 | 172.7 ± 13.4 | 205.8 ± 11.0 | 8.13 ± 0.97 | 1.56 ± 0.08 | 45.5 ± 3.3 |
500 | 191.7 ± 18.6 | 236.9 ± 13.1 | 9.87 ± 0.49d | 1.74 ± 0.10 | 43.6 ± 3.0 |
Note. Data are expressed as means ± SD.
aAbbreviation: di-isodecyl phthalate (DIDP)
bCon, control.
cT, testosterone.
dSignificantly different from testosterone (T), p < .05.
Table 2
Antiandrogenic Effects on Sex Accessory Tissues: Hershberger Assay Response to Phthalates in SD Castrated Male Rats After 10 d of Treatment
Experimental compoundsa and dose (mg/kg) | Seminal vesiclesb (mg)
| Ventral prostate (mg) | LABC (g)
| Cowper’s glands (mg)
| Glans penis (g) |
Conc | 34.8 ± 2.2 | 12.9 ± 0.5 | 99.1 ± 4.0 | 4.2 ± 0.6 | 35.5 ± 0.6 |
Td | 513.8 ± 35.4 | 183.8 ± 4.0 | 441.6 ± 24.3 | 40.1 ± 4.7 | 78.3 ± 5.1 |
DIDP |
|
|
|
|
|
20 | 485.2 ± 6.7 | 174.4 ± 24.1 | 407.5 ± 5.0 | 40.5 ± 3.5 | 76.1 ± 4.2 |
100 | 485.3 ± 10.2 | 175.5 ± 17.2 | 407.6 ± 39.8 | 40.6 ± 4.3 | 78.8 ± 6.3 |
500 | 469.2 ± 13.0e | 145.8 ± 20.4e | 449.8 ± 24.3 | 44.8 ± 3.3 | 82.5 ± 5.9 |
Note. Data are expressed as mean ± SD.
aAbbreviation: di-isodecyl phthalate (DIDP)
bSeminal vesicles were measured together with coagulating gland.
cCon, control.
dT testosterone.
eSignificantly different from testosterone (T), p < .05.
Applicant's summary and conclusion
- Conclusions:
- The antiandrogenic effects of phthalate, di-isodecyl phthalate (DIDP) was investigated by Hershberger assay in castrated male rats. Seminal vesicle weight and ventral prostrate weight were both decreased in the high dose group (500 mg/kg bw/day). However no effects were observed on the weights of the levator ani/bulbocavernosus muscles (LABC), Cowper's glands, or glans penis.
- Executive summary:
The antiandrogenic effects of phthalate, di-isodecyl phthalate (DIDP) was investigated by Hershberger assay in castrated male SD rats. An androgen agonist, testosterone (0.4 mg/kg/d), was administered for 10 consecutive days by subcutaneous (sc) injection as a positive control. DIDP was also administered at 20, 100, or 500 mg/kg body weight (bw)/day orally in combination with testosterone (0.4 mg/kg/d, sc) for 10 consecutive days. In the testosterone-treated groups, glans penis, seminal vesicles, ventral prostate, and levator ani/bulbocavernosus muscles (LABC) weights were found to be significantly increased, as expected. Ventral prostate weight and seminal vesicles weight were significantly decreased only in animals treated with 500 mg/kg bw/day DIDP. No effects were observed on the weights of the levator ani/bulbocavernosus muscles (LABC), Cowper's glands, or glans penis.
these test results are inconsistent with a positive androgen antagonist result as specfied in the guideline, as a statsitically significant reduction (p<0.05) in any two or more of the five androgen dependent tissue weights was not accompanied by some degree of reduced growth in the reamining three target tissues.
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