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EC number: 947-004-7 | CAS number: -
- Life Cycle description
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
- EC Number:
- 947-004-7
- Molecular formula:
- C28H56O6 - C29H58O6 - C30H60O6
- IUPAC Name:
- Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-,C12-13-branched alkyl esters
- Test material form:
- liquid
- Details on test material:
- product
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Age at study initiation: no data
- Weight at study initiation: 190 - 220 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +- 2 °C
- Humidity (%): 55 +- 15 %
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 02-June-1992 To: 16-06-1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other:
- Remarks:
- (sesame seed oil)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 5000 mg/kg bw administered by stomach tube
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: every morning in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of organic bodys functions, tegumentary apparatus, mucosae conditions, somatomotor activity and sensorium conditions): daily
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- No clinical signs
- Body weight:
- Body weight gain was normal.
- Gross pathology:
- No effects on organs were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 in rats of Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was greater than 5000 mg/kg bw.
- Executive summary:
An acute oral toxicity test was carried out on a group of 10 rats (5 male and 5 female) using test material according to OECD guideline 401. The test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was administered at a dose of 5000 mg/kg by using a stomach tube. There were no cases of mortality and no toxicological signs during the study. The LD50 was greater than 5000 mg/kg bw and the test material was found to be non-toxic under experimental conditions.
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