Registration Dossier
Registration Dossier
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EC number: 607-155-9 | CAS number: 22769-97-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12/02/2004-17/03/2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-diethyl 2,3-bis(propan-2-ylidene)butanedioate
- EC Number:
- 607-155-9
- Cas Number:
- 22769-97-7
- Molecular formula:
- C14H22O4
- IUPAC Name:
- 1,4-diethyl 2,3-bis(propan-2-ylidene)butanedioate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratoires France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: +- 20% of the mean weight of any previously dosed animals
- Fasting period before study:
- Housing: Daily observation were performed at the time of delivery of the animals and during the period of acclimatization. Animals were housed in cages of standard dimensions with sawdust bedding.
- Diet (e.g. ad libitum): ad libitum except during the fasting experimental period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days before treatment in the laboratory animal house where the experimental took place
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 45%-65%
- Air changes (per hr): 10 times/ hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- No. of animals per sex per dose:
- 6 animals (3 animals per step)
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One mortality (1/3) occured during each step of the study: one on D1 during the step 1 and one on D2 during the step 2.
- Clinical signs:
- other: Step 1: On D1, slight decrease of locomotor activity to none locomotor activity, ptosis, piloerection or bent back, dyspnoea, loss of righting, reflex were noted in animals. Step 2: From D1 to D2, marked decrease of locomotor activity to none locomotor a
- Gross pathology:
- No organ or tissue gross finding were seen at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the experimental conditions adopted, oral administration of DONOR S1 (SUCCINATE) (batch 0300712) a caused two mortalities (2/6) at the dose of 2000 mg/kg in the female Sprague-Dawley Rat.
According to the Globally harmonised Classification System (GHS), DONOR S1 (SUCCINATE) is in category 5.
Under the experimental conditions adopted, the LD50 is higher than 2000 mg/kg bw.
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