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Diss Factsheets
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EC number: 468-890-7 | 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2005-08-15 to 2005-09-23
- 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:
- 2 005
- Report date:
- 2005
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: proDERM Standard Protocol-V05
- Version / remarks:
- V05
- Deviations:
- no
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid: viscous
- Details on test material:
- Chemical name: 2-(4-Hydroxy-3,5-dimethoxy-benzylidene)-malonic acid bis-(2-ethyl-hexyl) ester
CAS No.: 444811-29-4
Method
- Type of population:
- general
- Ethical approval:
- no
- Remarks:
- not needed for cosmetic formulation
- Subjects:
- - Number of subjects exposed: 215
- Sex: 51 male, 164 female
- Age: 46.2 +/- 12.9 years
- Clinical history:
- no information
- Controls:
- The vehicle (vaseline) without test item was used as a control for irritation in each volunteer
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: Human Repeat Insult Patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Hilltop Chambers, large
- Vehicle / solvent: Vaseline
- Concentrations: 5%
- Volume applied: 200 µL
- Testing/scoring schedule:
Induction Phase (3 weeks): Application 3 times per week, each patch applied for 48 hours (total number of applications: 9)
Resting phase (2 weeks)
Challenge phase (1 week): single application for 48 hours (total number of application: 1)
EXAMINATIONS
- Grading/Scoring system (Erythema):
0: No evidence of irritation
0.5: Equivocal reaction (minimal erythema, barely perceptible)
1: Definite erythema
2: Erythema, minimal edema, and/or minimal papules
3: Erythema, induration (edema), and papules
4: Erythema, induration (edema), and vesicles
5: Strong reaction, clearly spreading beyond test site
Results and discussion
- Results of examinations:
- The 215 volunteers have been investigated for erythema/edema at different time points during induction phase and once during the challenge phase. During induction, some volunteers showed erythema at score levels of 0.5 and 1. One volunteer showed a score of 2.
During challenge, no volunteer exhibited a score of 2 or greater. Moreover, the proportion of volunteers showing 0.5 and 1 scores was comparable to those of the induction phase.
Any other information on results incl. tables
tables see attached background material
Applicant's summary and conclusion
- Conclusions:
- Under the exposure conditions applied in this study, the test item did not indicate a potential for cumulative skin irritation.
During the challenge phase, the test item did not indicate a potential for producing a delayed contact hypersensitivity. - Executive summary:
The test item was investigated for its skin sensitizing potential in a Human Repeat Insult Patch Test (HRIPT) in 215 volunteers (male and female). The test material was applied as a 5% formulation in vaseline under occlusive conditions (Hill chamber). During induction, formulations with the test item were applied to each volunteer 3 times per week for 3 weeks. After a rest period of 2 weeks, the test formulation with 5% test item was applied once for 48 hours. No increase in the overall score (number and grade) was observed during challenge. Under the exposure conditions applied in this study, the test item did not indicate a potential for cumulative skin irritation.
During the challenge phase, the test item did not indicate a potential for producing a delayed contact hypersensitivity.
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