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EC number: 241-029-0 | CAS number: 16958-92-2
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP, no analytical verification of exposure concentrations, no haematology, no clinical chemistry, no food consumption, only 2 concentrations tested)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- yes
- Remarks:
- (no haematology, no clinical chemistry, no food consumption, only 2 concentrations tested)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Bis(tridecyl) adipate
- EC Number:
- 241-029-0
- EC Name:
- Bis(tridecyl) adipate
- Cas Number:
- 16958-92-2
- Molecular formula:
- C28H54O4 - C36H70O4
- IUPAC Name:
- 1,6-ditridecyl hexanedioate
- Details on test material:
- - Name of test material (as cited in study report): [Trade name]
- Chemical name: Di-tridecyl adipate
- Physical state: liquid
- Composition of test material, percentage of components: 100 % ditridecyl adipate
- CRU No.: 87102 (Lot C0507-1) and 88384
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River at Kingston
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 180 - 196 g; females: 159 - 196 g
- Fasting period before study: no data
- Housing: stainless steel hanging wire cages
- Diet: certified Purina rodent chow #5002; ad libitum
- Water: tap water delivered via automatic system; ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: MMAD = 0.9 ± 0.1 (high dose) and 1.1 ± 0.3 (low dose) / GSD = 1.8 ± 0.0 (high dose) and 1.9 ± 0.1 (low dose)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 400 L inhalation chambers constructed of stainless steel and glass
- Method of holding animals in test chamber: held in cages designed for the inhalation chamber
- System of generating particulates/aerosols: The aerosol was generated at ambient temperature by use of Laskin nebulizers. Pressurized air passed through the hollow stem of the nebulizer and exited at high velocity through holes in its side. This high velocity airstream passed over the top of hollow feed barrels and caused the aspiration of the liquid test material up into the feed barrel. The liquid was aerolized as it was drawn into the airstream by the relative negative pressure there. The liquid was sheared into small droplets. The larger aerosol particles were removed by impaction on the walls of a glass container around the nebulizer and by impaction in a secondary glass impactor. The aerosol was then diluted by the main airstream before entering the exposure chamber containing the animals.
- Temperature, humidity in air chamber: approx. 23 - 24°C, 58 - 60 % rel. humidity
- Air flow rate: 236 - 288 L/min
- Method of particle size determination: by use of a cascade impactor
TEST ATMOSPHERE
- Brief description of analytical method used: The concentration of aerosol in the exposure chamber was determined gravimetrically by drawing known volumes of air from the chamber through glass fiber filters and measuring the increase in weight of the filters (caused by the entrapment of essentially all aerosol present in the sampled air). The weight increase was divided by the volume of air sampled to give the aerosol concentration. Aerosol concentration was measured at least 3 times daily for exposed groups and once daily for sham-exposed controls.
The mass median aerodynamic diameter of the aerosol was determined once during each exposure by use of a cascade impactor.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- 6 h/day, 5 days/week (10 exposures)
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.25 and 0.51 mg/L
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
250 and 510 mg/m³
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once daily excluding weekends
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once daily excluding weekends
- Parameters: appearance, behaviour, excretory function, discharges
BODY WEIGHT: Yes
- Time schedule for examinations: shortly before study beginning, on days 1 and 8, and at necropsy - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Necropsies were performed on all animals. In the scheduled sacrifices, all rats were weighed, exsanguinated by bleeding from the postcaval vein, and necropsied. Organ weights were determined from liver, kidneys, thymus, and lung.
The following organs were grossly examined:
- abdominal cavity
- adrenal
- aorta
- bile duct
- bone
- brain
- diaphragma
- ear
- epididymides
- oesophagus
- eyes (optic nerves)
- body fat
- head (nasal passages)
- heart
- large and small intestine
- kidney
- lacrimal gland (plus exorbital)
- larynx
- liver
- lung
- lymph nodes (anterior mediastinal, axillary, brachial, cervical, iliac, lumbar, mesenteric, pancreatic, renal, thymic, tracheobronchial)
- mammary gland
- oral cavity
- ovary
- oviduct
- pancreas
- penis
- pituitary
- preputial glands
- prostate
- salivary gland
- seminal vesicle
- skin
- spleen
- stomach
- testis
- thoracic cavity
- thymus
- thyroid
- tongue
- trachea
- urinary bladder
- uterus (body, horn, cervix)
The following tissues were preserved using 10% buffered formalin as a preservative:
- spleen
- liver
- trachea
- brain
- thymus
- nasal turbinates
- kidney
- tracheobronchial lymph nodes
- anterior mediastinal lymph nodes
- any gross abnormality
The respiratory tract was treated as follows:
The lungs, trachea, and larynx were removed in their entirety. The bronchi to the right middle lobe (RML) and right upper lobe (RUL) were tied off with a suture and cut distal to the suture. Both lobes were then blotted and weighed. The trachea were sliced just below the thyroids and the lungs inflated by insertion of a blunt needle through the slice and injection of a fixative containing 4% formaldehyde and 1% glutaraldehyde. The trachea were tied off when the lungs were inflated to a volume approximating normal in vivo resting volume. The lungs, trachea, and larynx were then immersed in fixative.
Skin, muscle, lower jaw, and brain were removed from the head except for the ear with the ear tag. Nasal turbinates were gently perfused with 20 mL of fixative applied through the external nares from a syringe with a blunt 15G needle without mechanical intrusion into the nares beyond 5 mm. The head was left in fixative for a minimum of 7 days before further processing.
HISTOPATHOLOGY: Yes
Histologic slices were prepared for the control and high-dose groups from the lung, nasal passages, trachea, tracheobronchial lymph nodes, liver, kidneys, and any abnormalities noted during necropsy. Slides were prepared from tissues which were embedded in paraffin or plastic and stained appropriately for diagnosis. - Statistics:
- ANOVA and Tukey's multiple range test
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
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No animals died during the study.
No abnormal treatment-related clinical signs were observed.
BODY WEIGHT AND WEIGHT GAIN
Body weight was not affected by exposure.
ORGAN WEIGHTS
No treatment-related changes were observed in the weight of the liver, kidneys, thymus, and right middle lung lobe (wet and dry weight).
GROSS PATHOLOGY
No treatment-related changes were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment-related abnormalities were seen microscopically in the nasal turbinates, lung, tracheobronchial lymph nodes, kidney, or liver.
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 510 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEC represents the highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Mean body weights
Sex |
Week |
Dose |
Low |
High |
Control |
|
|
Concentration [mg/m³] |
250 |
510 |
0.0 |
Males |
1 |
Mean ± SD |
370 ± 14 |
367 ± 15 |
369 ± 20 |
|
2 |
412 ± 17 |
407 ± 20 |
406 ± 23 |
|
|
3 |
457 ± 20 |
456 ± 21 |
449 ± 29 |
|
Females |
1 |
Mean ± SD |
255 ± 15 |
252 ± 16 |
255 ± 24 |
|
2 |
264 ± 13 |
261 ± 13 |
264 ± 24 |
|
|
3 |
280 ± 13 |
273 ± 17 |
280 ± 28 |
Table 2: Mean organ weights
Sex |
Organ |
Dose |
Low |
High |
Control |
|
|
Concentration [mg/m³] |
250 |
510 |
0.0 |
Males |
Kidneys |
Mean ± SD |
2.989 ± 0.243 |
3.032 ± 0.165 |
3.019 ± 0.343 |
|
Liver |
17.098 ± 2.014 |
17.688 ± 1.667 |
16.479 ± 2.634 |
|
|
Thymus |
0.509 ± 0.083 |
0.522 ± 0.067 |
0.455 ± 0.078 |
|
|
Lung, right middle |
0..177 ± 0.019 |
0.179 ± 0.018 |
0.185 ± 0.009 |
|
|
Lung, apical |
0.149 ± 0.013 |
0.153 ± 0.023 |
0.154 ± 0.014 |
|
Females |
Kidneys |
|
1.778 ± 0.099 |
1.781 ± 0.133 |
1.825 ± 0.164 |
|
Liver |
|
10.212 ± 0.776 |
9.598 ± 0.814 |
10.111 ± 1.324 |
|
Thymus |
|
0.355 ± 0.062 |
0.331 ± 0.080 |
0.354 ± 0.089 |
|
Lung, right middle |
|
0.143 ± 0.010 |
0.133 ± 0.013 |
0.135 ± 0.012 |
|
Lung, apical |
|
0.125 ± 0.017 |
0.112 ± 0.010 |
0.118 ± 0.016 |
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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