Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-783-7 | CAS number: -
- 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:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria of today standard methods (exposure period only 14 days, no examination of hematological and of clinical parametes, only limited number of organs examined)
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 examination of hematological and chlinical parameters, limited number of organs examined
- Principles of method if other than guideline:
- No guideline stated in report, but method used is similar to OECD TG 412. Goal of the study was to provide range-finding data on toxic effects of repeated exposures to diisotridecyl adipate aerosols as basis for a longer subchronic study.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Diisotridecyl adipate
- EC Number:
- 247-660-8
- EC Name:
- Diisotridecyl adipate
- Cas Number:
- 26401-35-4
- IUPAC Name:
- bis(11-methyldodecyl) adipate
- Details on test material:
- - Name of test material (as cited in study report): MCP 121, ditridecyl adipate
- Physical state: liquid
- Analytical purity: 100%
- Composition of test material, percentage of components: no data
- Purity test date: no data
- Lot/batch No.: C0507-1
- Expiration date of the lot/batch: 1991-01-01
- Stability under test conditions: stable
- Storage condition of test material: ventilation
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, Kingston, NY, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: males 180 - 195 g, females 159 - 196 g
- Housing: groups of in stainless steel hanging wire cages
- Diet (e.g. ad libitum): certified Purina rodent chow #5002, ad libitum
- Water (e.g. ad libitum): tap wateer delivered via automatic system, ad libitum
- Acclimation period: approx. 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -22°C
- Humidity (%): 40 - 60%
- Air changes (per hr): no dta
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: mass median diameter: group 1: 1.1 ± 0.3 µm
group 2: 0.9 ± 0.1 µm - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 400 L inhalation chambers constructed of stainless steel and glas
- Method of holding animals in test chamber: the hanging wire cages for housing were loaded into the inhalation chambers
- Source and rate of air: no data
- Method of conditioning air: no data
- System of generating particulates/aerosols: Laskin nebulizer; pressurized air at ambient temperature passed through the hollow stem of the nebulizer and exited at high velocity through holes in its side. This high velocity air stream 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 aerosolized 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 second glass impactor. The aerosol was then diluted by the main airstream before entering the exposure chamber containing the animals. The concentration of aerosol in the chamber was controlled by varying the design of the nebulizer, air pressure in the nebulizer, and airflow through the chamber.
- Temperature, humidity, pressure in air chamber: no data
- Air flow rate: no data
- Air change rate: no data
- Method of particle size determination: cascade impaction (once during each exposure) using a glass impactor
- Treatment of exhaust air: no data
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrical determination of test substance collected on glass fiber filters by drawing test atmosphere through them
- Samples taken from breathing zone: no data
VEHICLE (if applicable)
- Justification for use and choice of vehicle: no vehicle used - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gravimetrical determination by drawing air at a measured, controlled rate through glass fiber filters and determining the increase in weight of the filter (no significant amount of vapors was expected and vapors were not measured in the chamber air).
For nominal concentrations, the amount of test substance used for an individual test group exposure was determined by weighing. Division by the measured volume of air delivered to the exposure chamber yielded in the nominal concentration. - Duration of treatment / exposure:
- 14 days (10 exposures)
- Frequency of treatment:
- 6 hours per day 5 days a week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.25, and 0.51 mg/L (group 1 and 2); 0 mg/L (controls, group 3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: highest level anticipated for human subchronic exposure (0.5 mg/L) was selected as highest dose. A lower concentration (0.25 mg/L) was included in the test to provide data on a dose-response, if any unexpected toxicity was observed with the higher dose
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: during exposure at intervals of approx. 30 min, and once daily except on weekends
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily except on weekends
BODY WEIGHT: Yes
- Time schedule for examinations: shortly before exposure at day 1 (commencement of exposure) and day 8 and prior to sacrifice
FOOD CONSUMPTION: No
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (nasal turbinates, lung, tracheobronchial lymph nodes, kidney, liver, and any gross lesion) - Statistics:
- Data on body and organ weights were analyzed by Anova and Tukey's multiple range test for comparison of control and exposed 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
- 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
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No significant clinical effects were observed in exposed animals.
No mortality was observed during the experiment.
BODY WEIGHT AND WEIGHT GAIN
Body weight was not effected by exposure.
ORGAN WEIGHTS
No treatment-related alterations in organ weights were found.
GROSS PATHOLOGY
No effects observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No treatment-related microscopic abnormalities were found in the organs examined.
Effect levels
- Dose descriptor:
- NOAEC
- Basis for effect level:
- other: Only range-finding study with a limited set of parameters examined
- Remarks on result:
- not determinable
- Remarks:
- no NOAEC identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- During a 14 day inhalation exposure to two graduate diisotridecyl adipate aerosol concentrations using rats as test animals, no relevant test substance related adverse effects were observed. Only a limited number of parameters were examined (clinical signs, body weight, weights of selected organs, gross pathology, histology of selected tissues). Objective of this study was to provide range-finding data on toxic effects of repeated exposures. A NOAEC was not derived.
- Executive summary:
In a 14 day (subacute) inhalation toxicity study, diisotridecyl adipate was administered as aerosol to groups of 10 male and 10 female Sprague-Dawley rats by whole body exposure at concentrations of 0 (sham-control), 0.25 and 0.51 mg/L (analytical concentrations) for 6 hours per day, 5 days/week for a total of 10 days. Mass median diameter was ca 1.0 µm (respirable size). Objective of the study was to provide range-finding data on toxic effects of repeated exposures to aerosolized diisotridecyl adipate.
There were no compound related effects in mortality, clinical signs, body weight, weight of selected organs or gross pathology and histology of selected tissues. In addition, there was no indication of deposition of test material in and/or disposition from the lung and the nasal passages. A NOAEC was not derived (Mobil 1989).
This subacute inhalation toxicity study in the rat is not acceptable. It is a range finding study with only two (low) concentrations tested and only a limited number of parameters examined. It does not satisfy requirements of test guidelines in compliance with REACH.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.