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EC number: 239-996-9 | CAS number: 15872-89-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7/02/18 - 30/03/18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diheptyl succinate
- EC Number:
- 239-996-9
- EC Name:
- Diheptyl succinate
- Cas Number:
- 15872-89-6
- Molecular formula:
- C18H34O4
- IUPAC Name:
- 1,4-diheptyl butanedioate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- The EpiDerm (EPI-200) human tissue model (Lot# 27961) produced by MatTek Corporation was used for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Test materials were used as neat.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 30 µl of TA1, negative control (NC) and positive control (PC) (mesh was used for TA1, NC & PC) were applied topically to n=3 tissues per treatment group. N=3 tissues were prewet with 25 µl of DPBS. A 25 mg sharp application spoon was filled with test material (TA2). The spoon was leveled by gentle scratching of the excess material away and then applied.
- Duration of treatment / exposure:
- The treatments were performed at an interval of 1 minute between tissues and the tissues were incubated at 37C/5%CO2 for 35 ± 1 minutes.
- Duration of post-treatment incubation (if applicable):
- After 35 min, all plates were removed from the incubator and place into the biological safety cabinet until the 60-min exposure period was completedfor the first dosed tissue. The tissues were rinsed with sterile DPBS by filling and emptying the tissue inserts 15 times to remove any test material and transferred the tissues to 6-well plates pre-filled with 0.9 mL EPI-100-NMM media. The tissues were incubated in the incubator for next 24 ± 2 hours.
24 hours post-treatment the tissues were re-feed with 0.9 mL EPI-100-NMM medium and incubated at 37C/5%CO2 for an additional 18 ± 2 hours.
At the end of 18 ± 2 hours post-incubation period the tissues were removed from culture and MTT analysis was performed. - Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of 3 replicates
- Value:
- 101.513
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-irritating
- Executive summary:
Study 034-18 is intended to evaluate the skin irritation potential of topically applied Diheptyl Succinate using the EpiDerm Skin Irritation Test
Study Design
EpiDerm (EPI-200), produced by MatTek Corporation, was used to evaluate skin irritation potential of two topically applied test articles. Tissue viability following topical application of test articles was evaluated via MTT assay.
Results
PC (5% SDS) decreased tissue viability to 2.714%. The tissue viability of tissues treated with test article 1 (TA1 (Diheptyl Succinate)) was 101.513% hence was classified as non-irritants (NI).
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