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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 November 2012 to 04 April 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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 liquide (melting point 26°C)
- Details on test material:
- Test article name: Dimethyl sebacate
CAS number: 106-79-6
Batch number: 120801
Purity: 99.08%
Expiry date: 31 August 2013
Receipt date: 11 October 2012
Storage: in a sealed container, at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaGl
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Bicester, UK
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 17 to 20 g
- Housing: Individually in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989).
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, from Special Diets Services Ltd, Witham, UK, ad libitum
- Water (e.g. ad libitum): Mains water, ad libitum
- Acclimation period: 7 to 14 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: 06 November 2012 To: 20 November 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Group 1: Vehicle control
Group 2: low concentration (25% v/v)
Group 3: Intermediate concentration (50% v/v)
Group 4: High concentration (100% v/v) - No. of animals per dose:
- 4 animals per dose
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: Negative
- Lymph node proliferation response: Not applicable
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: The sensitivity and reliability of the test system was checked at least every six months. Preferred substances are a-hexylcinnamaldehyde (CAS Number 101-86-0) and mercaptobenzothiazole (CAS Number 149-30-4). A Stimulation Index of 3.0 or greater is expected from these substances.
TREATMENT PREPARATION AND ADMINISTRATION: Formulations were freshly prepared as required using 80% v/v acetone in olive oil on Days 1, 2 and 3. The formulations were stored at room temperature, in sealed, air-tight containers prior to dosing. Each mouse was manually restrained with both auditory pinnae left free. The outer aspect of both pinnae of each mouse was treated by direct application of the appropriate test or control formulation (0.025 mL/pinna) dispensed from an automatic micro pipette. - Positive control substance(s):
- other: a-hexylcinnamaldehyde (CAS Number 101-86-0) and mercaptobenzothiazole (CAS Number 149-30-4).
- Statistics:
- Not applicable
Results and discussion
- Positive control results:
- Positve control not included in this study but checked at least every six months.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Scintillation fluid with 5% w/v trichloroacetic acid: NA Vehicle control: NA Test article, 25% w/v: 1.8 Test article, 50% w/v: 1.9 Test article, 100 % w/v: 2.2 The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Scintillation fluid with 5% w/v trichloroacetic acid: 48 DPM Vehicle control: 1386 DPM Test article, 25% w/v: 2474 DPM Test article, 50% w/v: 2605 DPM Test article, 100 % w/v: 3056 DPM
Any other information on results incl. tables
Table 1
Observations, Body weights and Mortality data – Preliminary Screening
Test
Observations (Days) | |||||||
Concentration (% v/v in AOO) | Animal number | Body weight on Day –1 (g) | 1 | 2 | 3 | 4 | 5 |
100 | 416 | 18 | P | P | P | P | ü |
Key
AOO 80% v/v acetone in olive oil
P Greasy fur to head and neck
ü No clinical signs seen
Table 2
Scintillation counts and stimulation indices
Sample identity |
Number of sites yielding lymph nodes |
Disintegrations per minute* (DPM) |
Disintegrations per minute per node (DLM) |
Stimulation Index (SI) |
|||||
Scintillation fluid with |
-- |
48 |
-- |
-- |
|||||
Vehicle control |
8 |
1386 |
173 |
-- |
|||||
Test article, 25% v/v |
8 |
2474 |
309 |
1.8 |
|||||
Test article, 50% v/v |
8 |
2605 |
326 |
1.9 |
|||||
Test article, 100% v/v |
8 |
3056 |
382 |
2.2 |
* All scintillation counts corrected for the blank
SI = Test group DLM value
Control group DLM value
Table 3
Body weights
Body weights (g) | ||||
Concentration (% v/v) | Group number | Animal number | Day -1 | Day 6 |
Vehicle | 1 | 417418419420 | 19191920 | 19201921 |
25 | 2 | 421422423424 | 20191918 | 20192019 |
50 | 3 | 425426427428 | 17191919 | 18202019 |
100 | 4 | 429430431432 | 19191820 | 19192020 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The Local Lymph Node Assay demonstrated that Dimethyl Sebacate does not have the potential to cause skin sensitisation.
The test article did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). - Executive summary:
This study was conducted to assess the potential of the test article, Dimethyl Sebacate, to cause skin sensitisation in the mouse.
Following a preliminary screening test using the undiluted test article, the test article was prepared for administration at 25, 50 and 100% v/v in 80% v/v acetone in olive oil. Groups of four female CBA / CaCrl mice were subjected to topical applications of vehicle or of one of the test formulations to the outer aspect of the auditory pinnae once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated 3H-methyl thymidine was injected intravenously into each mouse. Approximately five hours later the auricular lymph nodes were recovered from each animal. The nodes from mice subjected to the same treatment were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter.
Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
Concentration of test article in applied formulation (%w/v)
25%
50%
100%
Stimulation Index
1.8
1.9
2.2
The Local Lymph Node Assay demonstrated that Dimethyl Sebacate does not have the potential to cause skin sensitisation.The test article did not meet the criteria for classification as a sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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