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Diss Factsheets
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EC number: 944-953-9 | CAS number: 73326-59-7
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14 August 2017 - 22 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- internal approved standard method
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- but GCP compliance (according to ICH Guideline E6)
Test material
- Reference substance name:
- diethyl 2-methylidenebutanedioate
- EC Number:
- 607-321-0
- Cas Number:
- 2409-52-1
- Molecular formula:
- C9H14O4
- IUPAC Name:
- diethyl 2-methylidenebutanedioate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 105 subjects completed the study
- Sex: male/female
- Age: 18-78 years - Clinical history:
- Exclusion Criteria:
- Ill health
- Under a doctor's care or taking medications which could influence the outcome of the study
- Pregnancy or nursing
- A history of adverse reactions to cosmetics or other personal care products - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: absorbent pad + adhesive dressing
- Concentrations: 1.1%
- Volume applied: 0.2 mL
- Testing/scoring schedule: Patches were applied three times per week (e.g., Monday, Wednesday, and Friday) for a total of nine applications. Challenge exposure two weeks after the final Induction patch application.
- Removal of test substance: twenty-four hours after application
EXAMINATIONS
- Grading/Scoring system: 0 = No visible skin reaction, 0.5 = Barely perceptible, 1 = Mild, 2 = Moderate, 3 = Marked, 4 = Severe, E = Edema, D = Dryness, S = Staining, P = Papules, V = Vesicles, B = Bullae, U = Ulceration, Sp = Spreading
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 105
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, test material (1.1%), indicated no potential for dermal irritation or allergic contact sensitisation.
- Executive summary:
A human repeated insult patch test was performed to determine the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitization. One hundred 115 qualified subjects, male and female, were selected for this evaluation. 105 subjects completed the study. The remaining subjects discontinued their participation for various reasons, none of which were related to the application of the test material.
The upper back between the scapulae served as the treatment area. Approximately 0.2 mL of the test material, or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing. This was then applied to the appropriate treatment site to form an occlusive patch. For induction patches were applied three times per week for a total of applications. The induction patches were removed twenty-four hours after application and the erythema were scored. Approximately two weeks after the final Induction patch application, a challenge patch was applied to a virgin test site adjacent to the original Induction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic Day 1 and Day 3 post-application.
Observations remained within normal limits throughout the test interval. Under the conditions of this study, test material (1.1%) indicated no potential for dermal irritation or allergic contact sensitisation.
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