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EC number: 224-081-9 | CAS number: 4196-89-8
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Subacute repeated dose toxicicity study according to respective guideline under GLP conditions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 407
- GLP compliance:
- yes
- Type of method:
- in vivo
Test material
- Reference substance name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- EC Number:
- 224-081-9
- EC Name:
- 2,2-dimethylpropane-1,3-diyl dibenzoate
- Cas Number:
- 4196-89-8
- Molecular formula:
- C19H20O4
- IUPAC Name:
- 3-(benzoyloxy)-2,2-dimethylpropyl benzoate
- Reference substance name:
- 3-hydroxy-2,2-dimethylpropyl benzoate
- Cas Number:
- 5522-92-9
- Molecular formula:
- C12H16O3
- IUPAC Name:
- 3-hydroxy-2,2-dimethylpropyl benzoate
- Test material form:
- solid: crystalline
- Details on test material:
- Batch No.: GSOH 140121
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 weeks
- Housing: groups of 5 animals per sex
- Diet ad libitum
- Water ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on exposure:
- The test substance formulated in polyethylene glycol 400 and administered daily for 28 days by oral gavage.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chemical analyses of formulations preparations were conducted once during the study to assess accuracy, homogeneity and stability over 5 hours.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily
- Duration of test:
- After 28 days of treatment animals were sacrificed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test substance formulated in polyethylene glycol 400 and administered daily for 28 days by oral gavage.
The following parameters were evaluated:
- clinical signs
- functional observation test
- body weight and food consumption
- clinical pathology and macroscopy at termination
- organ weights and histopathology on a selection of tissues as required by the guideline
GROSS PATHOLOGY: Yes
- organ weights:
adrenal glands, brain, epididymides, heart, kidneys, liver, ovaries, spleen, testes, thymus, uterus including cervix, prostate, seminal vesicles, thyroid including parathyroid
HISTOPATHOLOGY: Yes
adrenal glands, aorta, brain, caecum, Cervix, clitoral gland, colon, duodenum, epididymides, eyes, female mammary gland, femur including joint, heart, ileum, jejunum, kidneys, larynx, lacrimal gland exorbital, liver, lung infused with formalin, lymph nodes mandibular and mesenteric, nasopharynx, oesophgus, ovaries, pancreas, Peyer's patches, pituitary gland, preputal gland, prostate gland, rectum, salivary gland, sciatic nerve, seminal vesicles including coagulating glands, skeletal muscles, skin spinal cord, spleen, sternum with bone marrow, stomach, testes, thymus, thyroid gland including parathyroid, trachea, urinary bladder, uterus, vagina - Statistics:
- Dunnett's test, the Steel test, Fisher Exact test, Kruskal Walis test
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- other: NOAEL (reproductive organs)
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Based on the results from organ weights and macroscopic and microscopic examination
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: Referring to the parameters examined. The test item was tolerated up to 1000 mg/kg bw/day without toxicologically relevant effects.
Observed effects
No mortality occurred during the study period.
Salivation was observed in all females and most males at 1000 mg/kg bw/day and most males at 300 mg/kg bw/day on several days after dosing.
BODY WEIGHT AND WEIGHT GAIN
Body weights and body weight gain of treated animals remained in the same range as controls over the study period.
ORGAN WEIGHTS
Organ weights or organ to body weight ratios of treated animals were similar to those of control animals.
GROSS PATHOLOGY
Macroscopic observations at necropsy did not reveal any alterations that were considered to have arisen as a result of treatment.
HISTOPATHOLOGY: NON-NEOPLASTIC
There were no microscopic findings recorded that could be attributed to treatment with the test substance.
Applicant's summary and conclusion
- Conclusions:
- From the results presented in the report a definitive No Observed Adverse Effect Level (NOAEL) for 2,2-dimethylpropane-1,3-diyl dibenzoate of at least 1000 mg/kg bw/day was established due to the lack of general toxicity and due to the lack of affected male and female reproductive organs.
- Executive summary:
Male and female Wistar rats received daily 0, 100, 300 or 1000 mg/kg bw/day dissolved in polyethylene glycol 400 by gavage over a period of 28 days. The examinations were done according to OECD TG 407 under GLP conditions. Considering male and female reproductive organs no adverse effects were reported. Therefore a NOAEL (reproductive organs) at least 1000 mg/kg bw/day was established.
Overall, from the results presented in the report a definitive No Observed Adverse Effect Level (NOAEL) for 2,2-dimethylpropane-1,3-diyl dibenzoate of at least 1000 mg/kg bw/day was established due to the lack of general toxicity and due to the lack of affected male and female reproductive organs.
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