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EC number: 214-223-8 | CAS number: 1115-30-6
- 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 18 September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study according to GLP.
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:
- other: EC-Guideline 92/69, Method B.1.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Diethyl acetylsuccinate
- EC Number:
- 214-223-8
- EC Name:
- Diethyl acetylsuccinate
- Cas Number:
- 1115-30-6
- Molecular formula:
- C10H16O5
- IUPAC Name:
- 1,4-diethyl 2-acetylbutanedioate
- Reference substance name:
- Diethylacetylsuccinat (DEAS)
- IUPAC Name:
- Diethylacetylsuccinat (DEAS)
- Details on test material:
- - Name: "ACETYLBERNSTEINSÄUREDIETHYLESTER".- Chemical name: Acetonyl succinic acid diethylester.-Trade name: Diethylacetylsuccinat (DEAS).- CAS No.: 1115-30-6.- EINECS No.: 2142238.- Batch No.: SLBA 004.- Supplier: Sponsor.- Purity: 98 % (min.).- Solubility in water: 15 g/l (at 20 °C).- Density: 1.081 g/cm3 (at 20 °C).- Melting point: -8 °C.- Boiling point: 180-183 °C (at 67 mbar).- Flash-point: > 110 °C.- Ignition temperature: 385 °C.- Appearance: Light yellow liquid.- Odour: Perceptible.- Conditions of storage: In the refrigerator, in the dark.- Stability at conditions of storage: 12 months.- Stability at ambient temperature: 6 months.- Date of expiry: 31 December 1998.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Forschungsinstitut für Versuchstierzucht, A-2325 Himberg.- Age at study initiation: Approximately 8 weeks (males) and 12 weeks (females) at the time of administration.- Weight at study initiation: female mean: 164g and male 211g, for further information please see: "Any other information on results incl. tables"- Fasting period before study: Feed was withdrawn the evening before administration of the test substance and was offered again about three hours afterwards.- Housing: 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.- Diet: Altromin 1314 forte, gamma irradiated with 25 kGy 60Co, adlibitum (Producer: Altromin GmbH, D-32791 Lage). - Water: Tap water, offered in Makrolon bottles with stainless steel canules, ad libitum.- Acclimation period: 6 days.ENVIRONMENTAL CONDITIONS- Temperature (°C): Average of 22 °C.- Humidity (%): Average of 55 %.- Air changes (per hr): 12 per hour.- Photoperiod: Artificial light from 6 a.m. to 6 p.m.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLECorn oil was used for the suspension of the test substance. The suspension was prepared freshly before administration and was given within 20 minutes afterwards. A peroral administration was performed once in the morning by stomach intubation using a metal gavage. The dose volume was 10 ml per kg body weight. The individual dose volumes were calculated using the body weights determined at the day of the administration.CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: In a range finding study three groups of one male and one female each were dosed with 200, 1000 or 2000 mg per kg body weight. All animals survived for 14 days p.a. Therefore it was decided to perform a limit-test with one dose of 2000 mg per kg body weight. Both animals, dosed with 2000 mg/kg in the preliminary test, were included into the main study.
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 7 males and 7 females (including the animals for the rangefinding study.
- Control animals:
- no
- Details on study design:
- 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 was determined before administration, 7 days p.a. and 14 days p.a.All animals were killed by CO2 14 days p.a. and subjected to a necropsy including a gross pathological examination.
Results and discussion
- Preliminary study:
- In a range finding study three groups of one male and one female each were dosed with 200, 1000 or 2000 mg per kg body weight. All animals survived for 14 days p.a. Therefore it was decided to perform a limit-test with one dose of 2000 mg per kg body weight. Both animals, dosed with 2000 mg/kg in the preliminary test, were included into the main study.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- other: All animals were affected in any way. The findings were:- Central nervous effects:Motor excitation or sedation, catalepsy, tremor and/or hyperalgesia in 3 males and onefemale immediately after administration of the test substance and lasting to a maximum
- Gross pathology:
- Pale glandular stomach mucosa in one male and in one female animal were noted. All other animals were normal at the post mortem examination.For further details please see: "Any other information on results incl. tables "
Any other information on results incl. tables
Table 1: Synopsis of the results
Animal | Sex | Dose | Number of animals | ||
No. |
| (mg/kg) | exposed | affected | dead |
1 - 5 | m | 2000 | 5 | 5 | 0 |
6 - 10 | f | 2000 | 5 | 5 | 0 |
Table 2: Body weights and body weight gains Individual data, means and standard deviations SD.
Dose | Animal | Body weight (g) | Body weight gain (g) | ||||
(mg/kg) | No. | before | 7 days | 14 days | death | 0-7 days | 7-14 days |
2000, m | 1 | 171 | 244 | 297 | - | 73 | 53 |
| 2 | 222 | 292 | 339 | - | 70 | 47 |
| 3 | 238 | 305 | 339 | - | 67 | 34 |
| 4 | 215 | 283 | 321 | - | 68 | 38 |
| 5 | 210 | 272 | 303 | - | 62 | 31 |
| mean | 211 | 279 | 320 | - | 68 | 41 |
| SD | 25 | 23 | 20 | - | 4 | 9 |
2000, f | 6 | 170 | 205 | 220 | - | 35 | 15 |
| 7 | 167 | 199 | 221 | - | 32 | 22 |
| 8 | 161 | 200 | 209 | - | 39 | 9 |
| 9 | 159 | 202 | 223 | - | 43 | 21 |
| 10 | 164 | 195 | 197 | - | 31 | 2 |
| mean | 164 | 200 | 214 | - | 36 | 14 |
| SD | 4 | 4 | 11 | - | 5 | 8 |
Table 3: Observations in life.
A grade of severity was recorded where applicable (low - mid - high).
Findings | Dose | No. of the affected animal | Observation time first last | Maximum grade of severity |
normal at any time | 2000, m | none | - / - | - |
| 2000, f | none | - / - | - |
chromodacryorrhoea | 2000, m | 3 | 0.5 h / 3 d | low |
|
| 4 | 1 h / 1 d | low |
| 2000, f | 10 | 2 h / 1 d | low |
hyperalgesia | 2000, f | 6 | 2 h / 6 h | - |
motor excitation | 2000, m | 1 | 0.5 h / 6 h | - |
| 2000, f | 6 | 0.5 h / 1 d | - |
piloerection | 2000, m | 1 | 0.5 h / 2 d | low |
|
| 2 | 0.5 h / 1 d | medium |
|
| 3 | 0.5 h / 2 d | low |
|
| 4 | 0.5 h / 2 d | low |
|
| 5 | 0.5 h / 1 d | low |
| 2000, f | 6 | 0.5 h / 10 d | medium |
|
| 7 | 0.5 h / 1 d | low |
|
| 8 | 0.5 h / 1 d | low |
|
| 9 | 0.5 h / 1 d | low |
|
| 10 | 0.5 h / 1 d | low |
righting reflex catalepsy | 2000, m | 2 | 1 h / 2 h | - |
sedation | 2000, m | 2 | 0.5 h / 1 d | medium |
|
| 3 | 0.5 h / 1 d | low |
tremor | 2000, f | 6 | 6 h / 6 h | - |
Table 4: Necropsy findings
SYSTEM | Dose | Sex | Nos. of the affected |
Normal | 2000 | m | 2, 3, 4, 5 |
| 2000 | f | 7, 8, 9, 10 |
ALIMENTARY SYSTEM |
|
|
|
Glandular stomach, mucosa, pale | 2000 | m | 1 |
| 2000 | f | 6 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- The LD50,oral of "diethyl acetylsuccinate" is higher than 2000 mg/kg body weight in rats. Therefor no classificatio is required according to DSD and CLP.
- Executive summary:
The aim of the study was to investigate acute toxic effects of the test substance after a single peroral administration. The guidelines EC 92/69, method B.1., and OECD 401, 1987, were applied.
"Diethyl acetylsuccinate", freshly suspended in corn oil, was administered once orally by stomach intubation to Him:OFA Sprague Dawley rats. The dose was 2000 mg per kg body weight. The dose volume was 10 ml per kg body weight.
The test substance caused transient central nervous effects and signs of reduced well-being at the dose of 2000 mg/kg body weight. No mortality occurred.
The LD50,oral of "diethyl acetylsuccinate" is higher than 2000 mg/kg body weight in rats.
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