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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- 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: Young adult animals (female animals approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (± 20% of the mean weight)
- Fasting period before study: feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum
- Housing: single housing (Makrolon cage, type I)
- Diet (e.g. ad libitum): R/M maintenance, low phytoestrogen; Ssniff, Spezialdiäten GmbH (Soest, Germany), ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C *+/- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Solution in corn oil Ph.Eur - Doses:
- 2000 and 300 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter, on the last day of observation and on the day of death or sacrifice moribund starting with study day 1. Clinical signs for each animal were recorded several times on the day of administration and at least once during each workday thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg bw: two animals were found dead and one animal was sacrificed in a moribund state on study day 1.
300 mg/kg bw: No mortality occurred. - Clinical signs:
- other: 2000 mg/kg bw: in all animals impaired general state, cowering position, piloerection and dyspnea from hour 3 until hour 5 after administration. In one animal, piloerection persisted until study day 1 after administration, additional findings at this read
- Gross pathology:
- The following macroscopic pathologic findings were observed in the animals that died or in the single animal which was sacrificed in a moribund state (2000 mg/kg bw test group, 3 females): Red to dark brown discoloration of the small intestine and its contents in two animals; Dark spotted discoloration of the liver in two animals; Enlarged, dark red spotted stomach in all animals (haemorrhages in the single, moribund sacrificed animal).
The following macroscopic pathologic findings were noted in the animals examined on the last day of observation (second 300 mg/kg bw test group, 1 female): Red discoloration of the small intestine and its contents. There were no macroscopic pathological findings in five animals of both 300 mg/kg bw test groups sacrificed at the end of the observation period.
Any other information on results incl. tables
Mortality
Mortality |
|
Dose (mg/kg bw): |
2000 |
Sex: |
female |
Administration: |
1 |
No. of animals: |
3 |
Mortality (animals): |
3 |
Mortality |
||
Dose (mg/kg bw): |
300 |
300 |
Sex: |
female |
female |
Administration: |
1 |
2 |
No. of animals: |
3 |
3 |
Mortality (animals): |
No mortality |
No mortality |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions of this study the median lethal dose of Laromer IPGA after oral administration was found to be > 300 mg/kg bw - 2000 mg/kg bw in rats.
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