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EC number: 233-897-4 | CAS number: 10420-33-4
- 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
- Study period:
- 21 April 1998 to 16 September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dimethyl acetylsuccinate
- EC Number:
- 233-897-4
- EC Name:
- Dimethyl acetylsuccinate
- Cas Number:
- 10420-33-4
- Molecular formula:
- C8H12O5
- IUPAC Name:
- dimethyl 2-acetylsuccinate
- Details on test material:
- Name: "ACETYLBERNSTEINSÄUREDIMETHYLESTER".
Chemical name: Acetylsuccinic-acid-dimethylester.
Trade name: Dimethylacetylsuccinat (DMAS).
CAS No.: 10420-33-4.
EINECS No.: 2338974.
Batch No.: SK FE 401.
Purity: Min. 99 %.
Melting point: 33 °C.
Boiling point/range: 129 - 134 mbar °C.
Flash-point: 128 °C.
Igniting temperature: 340 °C.
Explosive limits: 0.72 - 11.1 Vol%
Vapour pressure: <1 hPa at 20 °C.
Density: 1.16 g/cm3 at 20 °C.
Appearance: Light yellow congealed mass.
Odor: Perceptible.
Solubility in water: 30 g/l at 20 °C.
Conditions of storage: In the refrigerator, in the dark.
Stability at conditions of storage: 12 month.
Stability of the test substance preparation: 6 month.
Date of expiry: 31.12.1998
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species, strain: Rats, Sprague Dawley, Him:OFA, SPF.
Supplier: Forschungsinstitut für Versuchstierzucht, A-2325 Himberg.
Number of animals and sex: 5 males and 5 females.
Age: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.
Hygiene: Improved hygienic conditions.
Room number: EH1-22.
Room temperature: Average of 23 °C.
Relative humidity: Average of 56 %.
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm x 15 cm). Wire mesh lids. Sanitation of cages once a week.
Bedding material: Aspen wood chips, type "4 HV" (Finn Tapvei Oy, SF-73620 Kortteinen), autoclaved. Bedding material was changed weekly.
Feed: Altromin 1314 forte, gamma irradiated with 25 kGy 60Co, ad libitum (Producer: Altromin GmbH, D-32791 Lage). Exception: Feed was withdrawn the evening before administration of the test substance and was offered again about three hours afterwards. Random samples of the feed are analysed for contaminants by Altromin.
Water: Tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.
Identification: Labelling with felt-tipped pen on the tail and on the cage.
Acclimatisation: 7 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Test substance preparations:
Corn oil was used for the suspension of the test substance. The suspension was prepared freshly before administration.
Route of administration and administration technique:
A peroral administration was performed within maximum 12 minutes after the preparation of the test substance suspension once in the morning by stomach intubation using a metal gavage. The dose volume was 10 ml per kg body weight. The individual dose volume was calculated using the body weight determined at the day of the administration. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observations in life:
Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.
Body weight and body weight gain:
Body weight was determined
before administration.
7 days p.a.
14 days p.a.
Body weight gain was calculated for each week of the study, i.e. between
0 and 7 d p.a.
7 and 14 d p.a.
Necropsy:
All animals were killed by CO2 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: All animals were affected. The findings were: Piloerection. Sedation. Piloerection was observed on the day of the administration of the test substance and lasted until a maximum of 4 days p.a. Sedation noted in 1/5 males and 1/5 females on the day of
- Gross pathology:
- There were no relevant findings.
- Other findings:
- Sex differences:
No sex difference in the response to the test substance was derived from signs in life and post mortem findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50,oral of "ACETYLBERNSTEINSÄUREDIMETHYLESTER" is higher than 2000 mg/kg body weight in rats.
- Executive summary:
It was the aim of the study to investigate acute toxic effects of the test substance after a single peroral administration.
Methods
Methods and investigations were performed in conformance with the following guideline:
EC-Guideline 92/69, method B.1.
OECD-Guideline 401, February 1987.
Administration
"ACETYLBERNSTEINSÄUREDIMETHYLESTER", freshly suspended in corn oil, wasadministered once to 5 male and 5 female Him:OFA rats (Sprague Dawley). The dose was 2000 mg per kg body weight.
Investigations
Body weight: before administration, 7 and 14 days p.a.
Clinical observations: at least once per day.
Necropsy: 14 days p.a.
Results
Mortality
Males and Females: All animals survived until 14 days p.a., i.e. the scheduled termination.
Body weight and body weight gain
Males and Females: Body weight and body weight gain were inconspicuous in all animals.
Clinical observations
Males and Females: All animales were were affected.
The findings were:
Piloerection.
Sedation, found in one male and one female.
The signs were observed on the day of administration of the test substance and lasted until a maximum of 4 d p.a. No toxic effects were noted at later times. Signs, noted in life, are interpreted as indicators of general malaise.
Necropsy findings
Males and Females: All animals were normal at terminal necropsy.
Sex differences
No sex difference in the response to the test substance was derived from signs in life and post mortem findings.
LD50
The LD50,oral of "ACETYLBERNSTEINSÄUREDIMETHYLESTER" is higher than 2000 mg/kg body weight in rats.
According to Commission Directive 2001/59/EC the test substance does not require classification for acute oral toxicity.
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