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EC number: 817-217-9 | CAS number: 116280-23-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03/08/2018 to 08/11/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(2-ethoxy-2-oxoethyl) 3-ethyl 2-methylidenepropanedioate
- EC Number:
- 817-217-9
- Cas Number:
- 116280-23-0
- Molecular formula:
- C10H14O6
- IUPAC Name:
- 1-(2-ethoxy-2-oxoethyl) 3-ethyl 2-methylidenepropanedioate
- Test material form:
- liquid
- Details on test material:
- - Purity: 98%
- Batch: MM212_S4
- Fabrication date: 18/07/2018
- Stabilizers:
7 ppm Methanesulfonic acid;
2000-3000 ppm 2,3,5-trimetilhidroquinona / Hydroquinone;
15 ppm Sulphuric acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source (supplier): Envigo RMS Spain S.L.
- Age at study initiation: 8 weeks old
- Weight at study initiation: Mean: 221.6g
- Fasting period: Overnight before administration and approx. 3-4h afterwards
- Diet (food): Teklad global 14% protein rodent maintenance diets 2914C (irradiated).
- Food availability: Ad libitum except for an overnight fast prior to dosing and approx. 3-4h afterwards.
- Water: Tap water
- Water availability: Ad libitum.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3ºC
- Humidity (%): 30-70%
- Light cycle: 12:12
IN-LIFE DATES: At the end of the 15-day observation period, all surviving animals were euthanized in a CO2 atmosphere.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 300 (starting dose) and 2000 mg/kg
- No. of animals per sex per dose:
- 6 animals per dose 300 mg/kg (in two dose steps: Group A (3 animals) and Group B (3 animals))
6 animals per dose 2000 mg/kg (in two dose steps: Group C (3 animals) and Group D (3 animals))
Therefore:
Total number of animals: 12 animals to perform 4 dose steps (A, B, C and D) - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observahhtions: 30min, 2h and 4h post-administration and once daily thereafter during the 15-day observation period.
- Frequency of weighing: once during the acclimatisation period, immediately before administration for dosing purposes (from 3-4h fasted animals), weekly thereafter and prior to sacrifice.
- Necropsy of survivors performed: yes
Any visible clinical signs, discomfort and mortality were recorded. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Group A - (Step 1) 300 mg/kg: No mortality ocurred.
Group B - (Step 2) 300 mg/kg: No mortality ocurred.
Group C - (Step 3) 2000 mg/kg: No mortality ocurred.
Group D - (Step 4) 2000 mg/kg: No mortality ocurred. - Clinical signs:
- other: Group A - (Step 1) 300 mg/kg: No abnormalities detected. Group B - (Step 2) 300 mg/kg: No abnormalities detected. Group C - (Step 3) 2000 mg/kg: No abnormalities detected. Group D - (Step 4) 2000 mg/kg: No abnormalities detected.
- Gross pathology:
- All animals killed at the end of the 15-day observation period.
Gross pathology observations: none
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At 2000mg/kg no mortality ocurred. Therefore, the oral median lethal dose (LD50) will be >2000 mg/kg (female rats).
Based on these results and according to the EU classification criteria outlined in Regulation 1272/2008 (CLP) the compound does not need to be classified. - Executive summary:
The objective of this study is to evaluate the acute oral toxicity of the test item in female Sprague-Dawley rats by the Acute Toxic Class Method (OECD guideline Nº 423).
6 female Sprague-Dawley rats were treated with test item by oral gavage administration at 300 mg/kg bw (starting dose) and other 6 at 2000 mg/kg bw. The rats were observed for 15 days.
At 300 and 2000 mg/kg bw, no mortality ocurred and no abnormalities were detected. Therefore, the oral median lethal dose (LD50) will be >2000 mg/kg (female rats).
Based on these results and according to the EU classification criteria outlined in Regulation 1272/2008 (CLP) the compound does not need to be classified.
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