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EC number: 203-764-5 | CAS number: 110-40-7
- 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
Endpoint summary
Administrative data
Description of key information
For that endpoint, two reliable studies were performed on the registered substance, assessing skin and eye irritation.
In the skin irritation study, the aim was to assess the local cutaneous tolerance of the "DIETHYL SEBACATE Batch 1727003" in vivo, in 13 volunteers. Tolerance was studied after a patch test carried out under occlusive conditions and lasting 48 hours. Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be irritant nor corrosive for the skin (score=0).
In the eye irritation study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "Diethyl sebacate batch 021006" is considered not to be cytotoxic.
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- no guideline followed
- Guideline:
- other: In vivo test on Human : patch-tests simples 48h
- GLP compliance:
- no
- Remarks:
- In vivo study (patch-tests simples 48h)
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: empty cup
- Amount / concentration applied:
- pure
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 24 hours after the patch is removed
- Number of animals:
- test on human
- Details on study design:
- 13 volunteers came to the EUROSAFE premises on the day the test started. They were identified by a 3-letter, 2-digit code. The test product was placed in the corresponding cup. The epidermal tests were then applied to the scapular area of the volunteers' backs. An empty cup was then used as a test control. Forty-eight hours after the application of the epidermal tests, they were delicately removed by the dermatologist and their location delimited with a skin pencil. Any skin reactions were read 30 minutes after the removal of the skin tests. A second reading by the dermatologist was carried out 24 hours after the first reading if a reaction was observed.
- Irritation parameter:
- overall irritation score
- Basis:
- other:
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the product caused no skin reactions in the 13 volunteers. In this study, with the limitations associated with the protocol (i.e. the inclusion of the limited number of 13 volunteers), the product, in pure mode, was shown to be non-irritating.
- Executive summary:
For that endpoint, one reliable study on the registered substance was performed.
In this study, the aim was to assess the local cutaneous tolerance of the "DIETHYL SEBACATE Batch 1727003" in vivo, in 13 volunteers. Tolerance was studied after a patch test carried out under occlusive conditions and lasting 48 hours.
Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be irritant nor corrosive for the skin (score=0).
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
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
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- no guideline followed
- Guideline:
- other: National decree 5 April 1971 on official methods of analysis for cosmetics and beauty products
- Principles of method if other than guideline:
- official method for the evaluation of the irritant potential by direct application of rabbit corneal fibroblasts on monolayers by the neutral red release method
- GLP compliance:
- not specified
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 10% - 25% - 50% - 100%
- Duration of treatment / exposure:
- 60 secondes
- Duration of post- treatment incubation (in vitro):
- Not specified
- Number of animals or in vitro replicates:
- Not specified
- Irritation parameter:
- other: percentage of mortality
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be cytotoxic.
- Executive summary:
For that endpoint, one reliable study on the registered substance was performed.
In this study, the aim was the evaluation of the occular irritant potential of "Diethyl sebacate batch 021006" by direct application to rabbit corneal fibrobast monolayers by the neutral red release method. Under the experimental conditions, sample "Diethyl sebacate batch 021006" is considered not to be cytotoxic.
The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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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