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Diss Factsheets
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EC number: 814-155-4 | CAS number: 13188-82-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline 12 Nousan No. 8147
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- EC Number:
- 814-155-4
- Cas Number:
- 13188-82-4
- Molecular formula:
- C9H14O4
- IUPAC Name:
- (2,2-dimethyl-1,3-dioxolan-4-yl)methyl prop-2-enoate
- Test material form:
- liquid
- Details on test material:
- Analytical study no. 20L00019
Batch: 0812-HS-0030
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Manufacturer, Batch 0812-HS-0030
- Purity: 96.2%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: 260g (males), 212g (females)
- Fasting period before study: no
- Housing: single
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): app 10
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 40cm² (at least 10% of body surface)
- fur clipped app. 24h before exposure
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.87 ml/kg b.w. - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: shortly before application, weekly thereafter
- Necropsy of survivors performed: yes (gross-pathology
- Clinical signs: recorded several times on the day of exposure, daily thereafter
- Other examinations performed:
- scoring of skin findings: 30-60min after removal of the substance, several times thereafter
- mortality: at least once daily
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
- Other findings:
- local effects males:
In all male animals, well-defined erythema (grade 2) was noticed on study day 1 after application, but progressed to moderate to severe erythema (grade 3, from study day 2 until study day 3, 7 or 10. Thereafter, well-defined erythema (grade 2) was observed in one animal from study day 6 until study day 7, while very slight erythema (grade 1) was seen in all animals from study day 8 until study day 10 or from study day 13 until study 14.
Slight edema (grade 2) was seen in all male animals from study day 2 until study day 3, 7 or 10, which regressed in three animals to very slight edema (grade 1) from study day 6 or 8 until study day 10 after application. Incrustations were noticed in four out of five animals from study day 6 until study day 7 or 10. In addition, scaling was seen in four male animals from study day 8 until study day 10 or from study day 13 until study day 14. In one of these animals, erythema and edema beyond the application site were observed from study day 6 until study day 10 after application.
local effects females:
In all female animals, well-defined erythema (grade 2) was noticed from study day 1 until study day 3 and persisted in one of these animals until study day 10 after application, followed by very slight erythema (grade 1) in this female from day 13 until day 14. In the other four female animals, moderate to severe erythema (grade 3) was seen from study day 6 until study day 7 or 10 after application. Thereafter, well-defined erythema (grade 2) was observed from study day 8 until study day 10 in two of these animals, which decreased in one of these animals to very slight erythema from day 13 until day 14. In the other two animals well-defined erythema (grade 2) was observed from study day 13 until study 14. Slight edema (grade 2) was seen in all animals from study day 2 until study day 7 or 10, while in three of these animals very slight edema (grade 1) was observed from study day 8 until study day 10.
In addition, incrustations were noted from study day 2 until study day 14 in two female animals and from study day 6 until study day 7 in another animal. Scaling was noticed in three animals from study day 6 or 8 until study day 10 or 14.
Furthermore, erythema and edema beyond the application area were seen in one animal from study day 6 until study day 10 after application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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