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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-431-4 | CAS number: 106-79-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 October 2012 to 05 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl sebacate
- EC Number:
- 203-431-4
- EC Name:
- Dimethyl sebacate
- Cas Number:
- 106-79-6
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,10-dimethyl decanedioate
- Test material form:
- other: Solid to liquid (melting point 23°C)
- Details on test material:
- Name: Dimethyl Sebacate
CAS number: 106-79-6
Batch number: 120801
Purity: 99.08%
Expiry date: 31 August 2013
Date of receipt: 11 October 2012
Storage: stored in a sealed container, at room temperature in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HsdHan:WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 to 9 weeks of age
- Weight at study initiation: 168 to 187g
- Fasting period before study: from the evening of the day prior to dosing (Day -1) until approximately 3 hours after dosing
- Housing: housed in groups of up to five during the acclimatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day –1), the rats were housed in groups of three in similar cages.
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, ad libitum
- Water (e.g. ad libitum): Mains water was provided, ad libitum
- Acclimation period: 7 to 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 65%
- Air changes (per hr): 15 to 20 air changes per hour.
- Photoperiod (hrs dark / hrs light): The rooms were illuminated by fluorescent strip-lights for twelve hours daily.
IN-LIFE DATES: From: 5 November 2012 To: 22 November 2012
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicalbe
- Amount of vehicle (if gavage): Not applicalbe
- Justification for choice of vehicle: Not applicalbe
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg
DOSAGE PREPARATION (if unusual): The test article was warmed to approximately 30ºC until it was in liquid form and dosed without dilution. The liquid test article was shaken immediately prior to use to ensure homogeneity.
- Rationale for the selection of the starting dose: Since there were no data to indicate that deaths may occur at dose levels of less than 2000 mg/kg, the first dose level was 2000 mg/kg. - Doses:
- A dose level of 2000 mg/kg with a specific gravity of 1.003 g/mL and a dose volume of 2 mL/kg
- No. of animals per sex per dose:
- 3 animals per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Rats were weighed on Day -1 (day before dosing) and on Days 1, 4, 8 and 15. Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs were recorded immediately post dose, at approximately 15 and 30 minutes post dose, hourly between 1 and 4 hours post dose (inclusive), twice daily on Days 2, 3 and 4 and once daily from the fifth to last day of the observation period.
- Necropsy of survivors performed: yes - Statistics:
- Not required
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No clinical signs were seen.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 1 Mortality data
Dose level (mg/kg) |
Mortality ratio |
2000 |
0/6 |
Table 2 Clinical signs following treatment
Dose level: 2000 mg/kg
Clinical sign |
Animal number |
||||||||||||
118 |
119 |
120 |
121 |
122 |
123 |
||||||||
No observations |
ü |
ü |
ü |
ü |
ü |
ü |
Key:
ü No clinical signs seen throughout the observation period
Table 3 Individual body weights and weekly increments
Dose level (mg/kg) |
Animal number |
Body weight (g) at: |
Increment (g) |
|||||
Day -1 |
Day 1 |
Day 4 |
Day 8 |
Day 15 |
Day 1 to 8 |
Day 8 to 15 |
||
2000 |
118 |
168 |
159 |
175 |
177 |
183 |
18 |
6 |
119 |
176 |
163 |
178 |
182 |
190 |
19 |
8 |
|
120 |
187 |
181 |
195 |
200 |
207 |
19 |
7 |
|
2000 |
121 |
177 |
169 |
180 |
189 |
185 |
20 |
-4 |
122 |
173 |
163 |
176 |
184 |
191 |
21 |
7 |
|
123 |
176 |
168 |
178 |
172 |
185 |
4 |
13 |
A minus symbol [-] indicates a body weight loss
Table 4 Necropsy findings
Dose level: 2000 mg/kg
Animal number |
Time and manner of death (Day) |
Necropsy comments |
118 |
15T |
No macroscopic changes
|
119 |
15T |
No macroscopic changes
|
120 |
15T |
No macroscopic changes
|
121 |
15T |
No macroscopic changes
|
122 |
15T |
No macroscopic changes
|
123 |
15T |
No macroscopic changes
|
T Animal killed by isofluoranean aesthesia followed by exsanguinations at completion of observation period
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The acute median lethal oral dose level of the test article, Dimethyl Sebacate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). - Executive summary:
This study was conducted to assess the acute toxicity of the test article, Dimethyl Sebacate, following a single oral administration to small groups of rats. The study design provides information for hazard assessment and classification and enables a chemical to be assigned to toxicity classes but severely restricts animal usage.
Groups of three female fasted rats were given the test article as a single dose on Day 1 by oral gavage at a dose level of 2000 mg/kg. All animals were killed on Day 15 and subsequently underwent a full necropsy.
There were no deaths and no clinical signs of reaction to treatment.
All rats achieved body weight gains over the study period.
No abnormalities were noted at necropsy.
The acute median lethal oral dose level of the test article, Dimethyl Sebacate, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.