Registration Dossier
Registration Dossier
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EC number: 943-149-5 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
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:
- Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
- Molecular formula:
- Representative, generic structures are given in "structural formula" wherein R = H or fatty acid residue and R' = sucrose residue, glycerol residue, H or alkali. Additional citric acid resp. its salt is present.
- IUPAC Name:
- Sucrose, glycerol and propane-1,2-diol, reaction products with C16-18(even numbered) fatty acids
- Test material form:
- solid: compact
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl.:(WI) BR - Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, D-8714 Sulzfeld
- Age at study initiation:-
- Weight at study initiation: m: 183 - 208 g, f: 158 - 203 g
- Fasting period before study: 16 hours
- Housing: Macrolon type III, max 5 animals
- Diet (e.g. ad libitum): ad libitum beside on day of application
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +- 2°C
- Humidity (%): 50 - 80 %
- Air changes (per hr):-
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % dispersion - Doses:
- Limit Test with 2000 mg/kg
- No. of animals per sex per dose:
- 5 male + 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Records on clinical observations: approx. 20 minutes, 1, 2, 3, 6 and 24 h, thereafter once daily up to day 14.
- Frequency of body weight determination: day 0, day 7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,
Results and discussion
- Preliminary study:
- The preliminary study with 1 male and 1 female animal showed no mortalities at a dose of 2000 mg/kg b.w.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed.
- Clinical signs:
- No clinical-toxicological symptoms observed.
- Body weight:
- Body weight changes showed a normal weight gain.
- Gross pathology:
- No test compound related macroscopic findings in the cranial-, thoracic and abdominal cavity.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The toxicity after a single oral intake of the test sample is above the dose limit 2000 mg/kg bw. The substance does not need to be classified according to CLP, EU GHS (Regulation (EC) No 1272/2008) and according to DSD (Directive 67/548/EEC).
- Executive summary:
In an acute oral toxicity study (limit test) performed according to the OECD Guideline 401 (Acute Oral Toxicity), groups of fasted Wistar rats (5/sex)
were given a single oral dose of Grilloten PSE 141 G in 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
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Grilloten PSE 141 G Batch 901 is practically nontoxic based on the LD50 in males/females.
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