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Diss Factsheets
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EC number: 948-946-1 | 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
Endpoint summary
Administrative data
Description of key information
Eye irritation in vitro: not irritant
Skin irritation in vitro: not irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 30869
- Expiration date of the lot/batch: 2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Skin model: API-200
Supplier: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- other: MTT reduction control
- Amount/concentration applied:
- 30µl
- Duration of treatment / exposure:
- 1h total (25min at room temperature and 35 minutes in the incubator)
- Duration of post-treatment incubation (if applicable):
- The tissues were incubated in the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours, the tissues were transferred into new 6-well plates pre-filled with 0.9 mL fresh medium and placed into the incubator for an additional 18 ± 2-hour post-incubation period.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 107
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The substance is considered not to require classification as a skin irritant, if the mean tissue viability exceeds 50%.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6-dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2-ethylhexyl) ester does not show a skin irritation potential in the EpiDermTM in vitro skin irritation test under the test conditions chosen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 30869
- Expiration date of the lot/batch: 2019-01-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature - Species:
- human
- Details on test animals or tissues and environmental conditions:
- EpiOcular OCL-200 kit from MatTek In Vitro Life Sciences, Bratislave, Slovakia
Reconstructed cornea: three-dimensional non-keratinized tissue construct composed of normal human-derived epidermal keratinocytes - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- other: MTT reduction control
- Amount / concentration applied:
- 50µl
- Duration of treatment / exposure:
- 30min
- Duration of post- treatment incubation (in vitro):
- 2h
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- other: tissue viability
- Value:
- 103
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results observed and by applying the evaluation criteria, it was concluded that Reaction mass of Hexanedioic acid, 1-cyclohexyl 6-(2-ethylhexyl) ester, Hexanedioic acid, 1,6-dicyclohexyl ester and Hexanedioic acid, 1,6-bis(2-ethylhexyl) ester does not show an eye irritation potential in the EpiOcular™ in vitro eye irritation test under the test conditions chosen.
Reference
Test substance |
|
tissue 1 |
tissue 2 |
mean |
inter-tissue variability [%] |
NC |
mean OD570 |
2.205 |
2.233 |
2.219 |
|
viability [% of NC] |
99.4 |
100.6 |
100.0 |
1.2 |
|
18/0104-1 |
mean OD570 |
2.308 |
2.242 |
2.275 |
|
viability [% of NC] |
104.0 |
101.0 |
102.5 |
3.0 |
|
PC |
mean OD570 |
0.810 |
0.671 |
0.741 |
|
viability [% of NC] |
36.5 |
30.2 |
33.4 |
6.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The potential to cause dermal irritation was assessed by a single topical application of 30 μL of the undiluted test substance to a reconstructed three-dimensional human epidermis model (EpiDerm™). The irritation test was performed with three EpiDerm™ tissues, which were incubated with the test substance for 1 hour followed by a 24 -hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test (MTT) to measure relative viability. The mean viability of the test-substance treated tissues was 107%. Based on the observed results, it was concluded, that the test substance does not show a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen. No further test for skin corrosion is required.
The potential to cause ocular irritation was assessed by a single topical application of 50 µL of the undiluted test substance to a reconstructed three-dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissues were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test (MTT). The mean viability of the test-substance treated tissues was 103%. Consequently, the test substance does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen. No further in vitro assays (BCOP) were required, since for non-irritant substances the differentiation between irritant and corrosive properties is unnecessary.
Justification for classification or non-classification
Since no indication of skin or eye irriation was detected in the corresponding in vitro assays, no classification according to Regulation (EC) No 1272/2008 (CLP) is required.
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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