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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- HRIPT
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HRIPT
- Principles of method if other than guideline:
- A unicentric, blind, noncomparative clinical study to evaluate primary
dermal irritability, accumulated and dermal sensitization, in order to prove
the topical compatibility of the investigational product. The study was
performed under maximized conditions, in which dressings containing the
product were applied on the back of the participants to prove the absence
of irritation and allergy potential. The practical part of the study lasted six
weeks, three weeks of application of the product, two weeks of rest of the
participants and a new application of the product in virgin area, in the
sixth week (challenge). The readings were performed according to the
reading scale recommended by the International Contact Dermatitis
Research Group (ICDRG). Dermatological assessments were performed at
the beginning and end of the study, or when there was evidence of a
positive or adverse reaction. - GLP compliance:
- yes
- Remarks:
- Good Clinical Practices
- Type of study:
- patch test
Test material
- Reference substance name:
- Diethyl sebacate
- EC Number:
- 203-764-5
- EC Name:
- Diethyl sebacate
- Cas Number:
- 110-40-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- diethyl sebacate
- Test material form:
- liquid
Constituent 1
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: Primary Dermal Irritability
- Hours after challenge:
- 96
- Group:
- test chemical
- Dose level:
- 1 patch
- No. with + reactions:
- 0
- Total no. in group:
- 51
- Clinical observations:
- None
- Key result
- Reading:
- other: Accumulated Dermal Irritability (ADI)
- Hours after challenge:
- 288
- Group:
- test chemical
- Dose level:
- 1 patch
- No. with + reactions:
- 0
- Total no. in group:
- 51
- Clinical observations:
- None
- Reading:
- other: Dermal Sensitization (DS)
- Hours after challenge:
- 288
- Group:
- test chemical
- Dose level:
- 1 patch
- No. with + reactions:
- 0
- Total no. in group:
- 51
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- • No potential for Primary Dermal Irritation was observed;
• No potential for Accumulated Dermal Irritation was observed;
• No Dermal Sensitization potential was observed.
According to the recommendation of the Safety Assessment Guide for
Cosmetic Products (ANVISA, 2012 - 2nd Edition), the product may be
declared Dermatologically Tested. - Executive summary:
TITLE
EN20-0222-01 - EVALUATION OF PRIMARY DERMAL IRRITABILITY,
ACCUMULATED DERMAL IRRITABILITY AND DERMAL SENSITIZATION
STUDY CODE
EN20-0222-01
SPONSOR BIOSYNTHIS
NAME OF THE INVESTIGATIONAL PRODUCT BIOSOLV DES
REFERENCE CODE OF THE INVESTIGATIONAL
PRODUCT
NOT CONCERNED
BATCHE OF THE INVESTIGATIONAL
PRODUCT
1727003
STUDY OBJECTIVE
To check for the absence of irritation potential (primary and accumulated
dermal irritability) and allergy (sensitization) of the investigational
product.
METHOD
A unicentric, blind, noncomparative clinical study to evaluate primary
dermal irritability, accumulated and dermal sensitization, in order to prove
the topical compatibility of the investigational product. The study was
performed under maximized conditions, in which dressings containing the
product were applied on the back of the participants to prove the absence
of irritation and allergy potential. The practical part of the study lasted six
weeks, three weeks of application of the product, two weeks of rest of the
participants and a new application of the product in virgin area, in the
sixth week (challenge). The readings were performed according to the
reading scale recommended by the International Contact Dermatitis
Research Group (ICDRG). Dermatological assessments were performed at
the beginning and end of the study, or when there was evidence of a
positive or adverse reaction.
POPULATION SAMPLE
Number of participants screened = 56;
Number of participants selected = 55;
Number of participants who completed the study = 51;
Number of participants with data used in conclusion = 51.
AREA OF APPLICATION : Back
DURATION OF THE STUDY : 13.APR.2020 to 21.MAY.2020
RESPONSIBLE RESEARCHER
Dr. Sérgio Schalka
Médico dermatologista
CRM 70.148 - SP
Link do currículo lattes: http://lattes.cnpq.br/5104492141816914
ETHICAL CONSIDERATIONS AND QUALITY
CONTROL
The study was conducted in accordance with the guidelines of the Good
Clinical Practices. Quality control runs at each step of the method.
RESULTS
• After the study period of Primary Dermal Irritability, none of the
52 participants who completed this stage had skin reaction;
• After the Accumulated Dermal Irritability period, none of the 51
participants who completed this stage had skin reaction;
• After the period of the Dermal Sensitization study, none of the 51
participants who completed this stage had skin reaction.
CONCLUSION
• No potential for Primary Dermal Irritation was observed;
• No potential for Accumulated Dermal Irritation was observed;
• No Dermal Sensitization potential was observed.
According to the recommendation of the Safety Assessment Guide for
Cosmetic Products (ANVISA, 2012 - 2nd Edition), the product may be
declared Dermatologically Tested.
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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