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EC number: 217-057-4 | CAS number: 1732-08-7
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 August 2017- 14 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 439 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 23 July 2009
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- French GLP Compliance Programme for chemical products (inspected on 30-31 January 2017 / signed on 27 April 2017)
Test material
- Reference substance name:
- Dimethyl heptanedioate
- EC Number:
- 217-057-4
- EC Name:
- Dimethyl heptanedioate
- Cas Number:
- 1732-08-7
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 1,7-dimethyl heptanedioate
- Test material form:
- liquid
- Details on test material:
- Name: Dimethyl Pimelate
Batch no.: 1601070000
Appearance: Oily liquid, colorless
CAS No.: 1732-08-7
EINECS-No.: 217-057-4
Molecular formula: C9H16O4
Purity: 98.54 % w/w
Production date: 04 Jul. 2016
Expiry date: 01. Aug. 2019
Storage: Fridge (2-8°C), keep away from humidity
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- Following the REACH bottom-up strategy, the EPISKIN™ Reconstructed Human Epidermis Model method was used to assess skin irritation as recommended in the OECD test guideline No. 439.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: SkinEthic RHE® model
- Tissue batch number(s): 17-RHE-088
- Production date: Not reported
- Shipping date: Not specified
- Delivery date: 29 August 2017
- Expiry date: 04 September 2017
- Date of initiation of testing: 23 August 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: 25 x 1 mL of DPBS (Dutscher - Batch No. 9130617)
- Observable damage in the tissue due to washing: The rinsed tissues were checked for any coloration and noted to be whitish, comparable to negative control tissues.
- Modifications to validated SOP: None reported
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1.0 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: ELx800 absorbance microplate reader (controlled every year and calibrated if necessary) supplied by BioTek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek
- Wavelength: 570 nm
- Filter: Not applicable
- Filter bandwidth: Not applicable
- Linear OD range of spectrophotometer: No data reported
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD570= 1.4, CV= 4.3% (specification: OC > 0.7)
- Barrier function: ET50 (Exposure time inducing 50% viability using Triton X-100 1%)= 4.3h (specification: 4.0h =< ET50 =< 10.0h)
- Morphology: well differenciated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum
- Contamination: : absence of bacteria, fungus and mycoplasma
- Reproducibility: not reported
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- There is no direct interaction between the test item and MTT.
- No need to add non-specific coloration control since the test item has no coloration potential.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the tissue viability after 42 minutes of exposure and 42 hours of post-treatment incubation is ≤ 50%.
- The test substance is considered to be non-irritant to skin if the viability after 42 minutes of exposure and 42 hours of post-treatment incubation is > 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16 μL of the test item was then applied to the epidermal surface.
- Concentration (if solution): not applicable
VEHICLE
not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL of DPBS
- Concentration (if solution): undiluted
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 16 μL of SDS
- Concentration (if solution): 5% w/v aqueous solution - Duration of treatment / exposure:
- Triplicate tissues were treated with the test item for an exposure period of 42 minutes at room temperature.
- Duration of post-treatment incubation (if applicable):
- At the end of the exposure period, tissues were rinsed and incubated at 37 °C, 5% CO2 in air for 41 hours in fresh medium.
- Number of replicates:
- 3 living tissues for test item, negative and positive controls
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean corrected percent viability
- Run / experiment:
- 1
- Value:
- 98.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 1.2%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not specified
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
- Range of historical values if different from the ones specified in the test guideline: Provided in the study report
Any other information on results incl. tables
Table 7.3.1/1: Mean OD570Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Skin | OD | Mean OD / disc (#) | Mean OD / product | Viability % | Mean viability % | SD | Conclusion | |
Negative control | 1 | 0.750 0.851 0.872 |
0.824 | 0.787 | 104.7 | 100.0 | 5.2 | |
2 | 0.770 0.795 0.813 |
0.793 | 100.8 | |||||
3 | 0.759 0.745 0.726 |
0.743 | 94.4 | |||||
Positive control | 4 | 0.008 0.009 0.010 |
0.009 | 0.009 | 1.1 | 1.2 | 0.2 | Irritant |
5 | 0.008 0.009 0.008 |
0.008 | 1.0 | |||||
6 | 0.010 0.010 0.013 |
0.011 | 1.4 | |||||
Test item | 22 | 0.646 0.681 0.713 |
0.680 | 0.774 | 86.4 | 98.4 | 10.8 | Non irritant |
23 | 0.795 0.796 0.804 |
0.798 | 101.4 | |||||
24 | 0.809 0.848 0.876 |
0.844 | 107.3 |
#: mean of 3 values (triplicate of the same extract)
OD: optical density
The optical density was measured after a 1:2 dilution of the formazan extracts in isopropanol.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test item Dimethyl Pimelate has to be considered as non-irritant to skin according to CLP regulation (EC) No.1272/2008. It is also not classified according to UN GHS regulation.
- Executive summary:
An in vitro skin irritation study was performed according to the OECD Guideline 439, the EU Method B.46 and in compliance with GLP, using the EPISKINTM reconstructed human epidermis model.
The test item Dimethyl Pimelate was applied, as supplied, at the dose of 16 μL to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) during 42 minutes. The application was followed by a rinse with 25 mL of DPBS and a 41 hours post-incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The mean percent viability of the treated tissues was 98.4%, versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate).
Under the experimental conditions of this study, the test item Dimethyl Pimelate has to be considered as Non-irritant to skin to skin according to CLP regulation (EC) No.1272/2008. It is also not classified according to UN GHS regulation.
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