Registration Dossier
Registration Dossier
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EC number: 700-786-1 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- 5 ml/kg instead of 2g/kg
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
- EC Number:
- 700-786-1
- Cas Number:
- 1194682-64-8
- IUPAC Name:
- Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 males and 5 females
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 5 ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- no anormal clinical sign
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 mL/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- other: no
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- the results in the mentioned study is: LD 50 (rat) >5ml/kg
- Executive summary:
The oral administration of Sophorolipids in rats up to 5ml/kg followed of an observational period of 14days allow to conclude:
- no mortality
-no clinical signs
-normal body weight increase in animals
- no mascroscopics findings
herewith the oral LD 50 in the test conditions is >5ml/kg bw
we conclude the substance is not toxic.
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