Registration Dossier
Registration Dossier
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EC number: 252-478-7 | CAS number: 35274-05-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: no GLP and limited data on method and results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1958
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The method used was based on scientifically accepted method.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Hexadecyl lactate
- EC Number:
- 252-478-7
- EC Name:
- Hexadecyl lactate
- Cas Number:
- 35274-05-6
- Molecular formula:
- C19H38O3
- IUPAC Name:
- hexadecyl lactate
- Test material form:
- not specified
- Details on test material:
- no details available except the batch number which was 9597
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Holtzman
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- The text animal were maintained on the regular diet of fox blox and water during the observation period of 7 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- A single dose of 5,10 and 20 ml /kg bw were administered intragastrically using a rigid stomach tube.
- Doses:
- 5-20ml per kg bw of rat
- No. of animals per sex per dose:
- 10
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 20 other: ml/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- none
- Body weight:
- no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Did not produce any vissible toxic effect.
- Executive summary:
The LD50 of the test material is more than 10 times than the maximum limit for classification of 2000 mg/kg bw.The results show that even at highest dose of 20ml/kg bw, no vissible toxic effect was seen.
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