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EC number: 227-999-8 | CAS number: 6065-82-3
- 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:
- From 23 September 1980 to 23 March 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant, comparable to guideline study with deviations not affecting the validity of the study. Study Report very well detailed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- yes
- Remarks:
- see "principles of method if other than guideline"
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- see "principles of method if other than guideline"
- Principles of method if other than guideline:
- Study perfomed prior to the adoption of guidelines. Overall, the study complies with the recommendations of the EU Method B.1 and OECD 401 guidelines except for the following: The minimum acclimatation period was 3 days instead of 5 days. The maximum volume of test material applied was 25 mL/kg instead of the recommended 10 mL/kg for rodents. Only hydric fasting was performed prior to dosing. In addition, according to the nowadays ethical considerations, the doses selected for the main study should not have included the dose causing 100 % mortality.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Ethyl diethoxyacetate
- EC Number:
- 227-999-8
- EC Name:
- Ethyl diethoxyacetate
- Cas Number:
- 6065-82-3
- Molecular formula:
- C8H16O4
- IUPAC Name:
- ethyl 2,2-diethoxy-acetate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre d'élevage IFFA-CREDO, 69210 Saint Germain sur l'Arbresle
- Age at study initiation: no data
- Weight at study initiation: 120-150 g
- Fasting period before study: only hydric fasting was peformed 16 hours prior to the administration of the test material.
- Housing: animals (5/cage), were housed in polycarbonate cages with stainless steel lid sized 42 cm x 27 cm x 15 cm. Cages were cleaned and sterilized once a fortnight, according to the Standard Operating Procedures of the testing laboratory.
- Bedding: Sawdust (non resinous and non African wood), dusted and autoclaved. Litter was changed once or twice a week.
- Diet: standardised pellets (reference 890 from NAFAG CH., Switzerland, 9202 GOSSAU SG, with complete composition attached to the Study Report). The residue analysis was performed and communicated by the diet supplier.
- Water: ad libitum, in 500 or 800 mL bottles made of polypropylene with rubber stopper and stainless steel pipette. The bottles were washed and sterilized once a fortnight. The drinking water was sterilized by membrane filtration (FG, Millipore 0.2µ). The microbiological analysis was perfomed by the testing laboratory, and the chemical analysis by the municipal laboratory (76000 Rouen).
- Minimum acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Cleaning: the animal unit rooms were cleaned according to the Standard Operating Procedures of the testing laboratory.
- Temperature (°C): 20-25
- Humidity (%): 30-80
- Air changes (per hr): 11
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 25 ml/kg
DOSAGE PREPARATION (if unusual): not applicable
RATIONALE FOR THE SELECTION OF DOSES:
A range finding test was performed: One male and one female per dose level were exposed to the following 3 doses: 5, 15 and 25 mL/kg bw (ca. 4950, 14850 and 24750 mg/kg bw). Clinical signs and mortalities were recorded up to 7 days post single exposure. No mortality was obserevd at the lowest dose level. 50% mortality was recorded at the medium dose (male died at Day2), and 100% mortality was observed for the highest dose level (male died at Day 1 and female at Day 2). - Doses:
- 5, 10, 13, 15 and 25 mL/kg bw corresponding to ca. 4950, 9900, 12870, 14850 and 24750 mg/kg bw .
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - A single oral administration was performed by gavage (Day 0).
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
1) Mortality was checked daily during the study and recorded at Day 0 (1 and 3 hours after administration of the test material), and then at Days 1, 4, 7 and 14.
2) Animals were weighted at Days 0, 4, 7 and 14 after oral administration of the test material, and weights were recorded.
3) Clinical signs: observations were performed during the first and the third hour following the test material administration, and then daily during the 14 days study period.
- Necropsy of survivors performed: yes. Macroscopic examinations were performed on main organs (liver, kidneys, heart, adrenals, spleen and stomach) of animals that died during the study, and animals that survived at the end of the study (Day 14), that were CO2-euthanised (Air Liquide, 27000 Evreux). Histopathological examinations were performed if required.
- Other examinations performed: no further examinations performed. - Statistics:
- The oral LD50 and its confidence limits were determined according to the Litchfield and Wilcoxon method (J. Pharmacol. Exp. Therap., 1949, 96, 99-113).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 14 850 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 12 573 - < 17 523
- Remarks on result:
- other: calculated based on the density of test material
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 15 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- > 12.7 - < 17.7
- Mortality:
- - 5 mL/kg bw: 0%
- 10 mL/kg bw: 20%
- 13 mL/kg bw: 10%
- 15 mL/kg bw: 60 %
- 25 mL/ kg bw: 100 %
Detailed recording of mortalities is presented in Table 1. - Clinical signs:
- other: - 5 mL/kg bw: During the first hour post dosing, animals were sleepy. This effects was fully reversed 3 hours post dosing. - 10 mL/ kg bw: 15, 30 and 60 minutes post dosing, slight drowsiness was noted in all animals. At Day 1, piloerection was obsereved
- Gross pathology:
- Animals that died during the study showed the following macroscopic findings:
- Discoloration areas in liver, spleen and/or kidneys
- Food stasis - Other findings:
- No further findings
Any other information on results incl. tables
Table 1 :Mortality
Doses (ml/kg) |
Number of animals |
Cumulative mortality |
||||||
J0 1h |
J0 3h |
J1 |
J4 |
J7 |
J14 |
% of mortality |
||
5 |
5 males 5 females |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 0 |
0 |
10 |
5 males 5 females |
0 0 |
0 0 |
1 0 |
2 0 |
2 0 |
2 0 |
20 |
13 |
5 males 5 females |
0 0 |
0 0 |
0 0 |
1 0 |
1 0 |
1 0 |
10 |
15 |
5 males 5 females |
0 0 |
0 0 |
2 1 |
4 2 |
4 2 |
4 2 |
60 |
25 |
5 males 5 females |
0 0 |
3 2 |
4 4 |
5 5 |
5 5 |
5 5 |
100 |
Table 2 :Weight evolution of animals
Doses (ml/kg) |
J0 |
J4 |
J7 |
J14 |
||||
Number of animals |
Mean ± SD (g) |
Number of animals |
Mean ± SD (g) |
Number of animals |
Mean ± SD (g) |
Number of animals |
Mean ± SD (g) |
|
5 |
10 |
145 ± 7 |
10 |
190 ± 13 |
10 |
201 ± 17 |
10 |
224 ± 17 |
10 |
10 |
140 ± 6 |
8 |
160 ± 10 |
8 |
174 ± 13 |
8 |
211 ± 19 |
13 |
10 |
124 ± 6 |
9 |
142 ± 5 |
9 |
159 ± 11 |
9 |
188 ± 16 |
15 |
10 |
134 ± 7 |
4 |
150 ± 9 |
4 |
174 ± 13 |
4 |
208 ± 23 |
25 |
10 |
129 ± 7 |
0 |
|
0 |
|
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test material was determined to be 15 mL/kg (ca. 14860 mg/kg). Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.
- Executive summary:
This GLP-compliant study was performed to assess the acute oral toxicity of the test material, according to a method comparable to EU Method B.1 and OECD Guideline 401.
Material and methods
The test material was administered unchanged by gavage to 5 groups of 10 Wistar rats (5 animals/sex/ dose), at the following doses determined in a range finding test: 5, 10, 13, 15 and 25 mL/kg bw corresponding to ca. 4950, 9900, 12870, 14850 and 24750 mg/kg bw.
Animals were monitored during the 1stand the 3rdhour following the test material administration, and then daily during the 14 days study period. Mortality was checked daily and animals were weighted at Days 0, 4, 7 and 14. Necropsy of survivors and died animals was performed. Macroscopic examinations were carried out on main organs (liver, kidneys, heart, adrenals, spleen and stomach), and histopathological examinations were performed if required.
Results
The weight evolution of animals was typical of the species used in this study.
The mortalities (%) of the tested doses (5, 10, 13, 15 and 25 mL/kg bw) were as follows: 0, 20, 10, 60 and 100.
The clinical signs ranged from a transient drowsiness at the lowest dose, to drowsiness, strong lethargy, breathing decrease, slight loss of equilibrium and slight lachrymation, with all animals dying at the highest dose.
The macroscopical examination of animals that died during the study showed discoloration areas in liver, spleen and/or kidneys, and food stasis.
Conclusion
Under the experimental conditions of this study, the oral LD50 of the test material was determined to be 15 mL/kg (ca. 14860 mg/kg). Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.
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