Registration Dossier
Registration Dossier
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EC number: 946-420-6 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-02-28 to 1996-03-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24 th, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- July 31st, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- EC Number:
- 946-420-6
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- BR strain (VAF plus)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 4-6 weeks
- Weight at study initiation: approx. 100 g
- Fasting period before study: over night
- Housing:Animals were housed in groups of up to 5, by sex, in grid-bottomed cages suspended over cardboard lined excreta trays
- Diet (e.g. ad libitum): ad libitum, pelleted diet (SQC Rat and Mouse Maintenance Diet No. 1 Expanded, Special Diet Services, Witham, Essex)
- Water (e.g. ad libitum): ad libitum, mains drinking water in polypropylene bottles
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-26°C
- Humidity (%): 34-60%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In a preliminary study in one female and one male rat a dose of 2000 mg/kg bw was applied. Since no deaths occurred during the preliminary study the test item was similarly administrered to 5 female and 5 male rats. - Doses:
- 2000 mg/kg bw
- 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: Observations were performed 30 min, 1h, 2h and 4h after dosing. Examinations were conducted daily thereafter. Bodyweight was recorded at the day of dosing and at day 1, 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- One female and one male rats were administered with 2000 mg/kg bw of the test item.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- not observed
- Clinical signs:
- other: not observed
- Gross pathology:
- no abnormalties observed at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item was > 2000 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD Guideline 401 (1987) and EU method B.1 (1992), groups of fasted, 4-6 weeks old, Sprague Dawley rats (5 female/5 male) were given a single oral dose ofpolyglycerin caprinatein water at a dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50 Males < 2000 mg/kg bw
Females < 2000 mg/kg bw
Combined < 2000 mg/kg bw
no mortality occurred at the applied dose /limit test
Polyglycerin caprinateis of low toxicity based on the LD50 in both sexes (not classified according to GHS criteria).
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