Registration Dossier
Registration Dossier
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EC number: 215-350-1 | CAS number: 1323-03-1
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: The study is non-GLP, but well described except for ommissions in experimental conditions like temperature and humidity.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 964
- Report date:
- 1964
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Thirty young adult rats were distributed into three dosage groups of each ten rats and exposed to various dosages of test material administered by intragastric intubation.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tetradecyl lactate
- EC Number:
- 215-350-1
- EC Name:
- Tetradecyl lactate
- Cas Number:
- 1323-03-1
- Molecular formula:
- C17H34O3
- IUPAC Name:
- tetradecyl 2-hydroxypropanoate
- Reference substance name:
- Ceraphyl 50
- IUPAC Name:
- Ceraphyl 50
- Test material form:
- other: liquid
- Details on test material:
- Batch #9639
Sample date: 24-02-1964
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Holtzman
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Type: young adult albino rats
Housing: in mesh bottom cages and fasted 24 h prior to dosing
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- yelow liquid
- Details on oral exposure:
- No further details.
- Doses:
- 0.5, 10, 20 ml/kg bw.
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- The rats received food and water ad libitum after dosage and were observed daily for 14 days following administration.
- Statistics:
- The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 20 mL/kg bw
- Based on:
- test mat.
- Mortality:
- Dosage Animals Number of deaths daily day 14
mL/kg dosed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 % Mortality
2.5 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
10.0 5 0 0 0 1 0 0 0 0 0 0 0 0 0 0 20
20.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
40.0 5 0 0 0 1 0 1 1 0 1 0 0 0 0 0 80 - Clinical signs:
- other: No details.
- Gross pathology:
- No details.
- Other findings:
- No details.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of Ceraphyl 50 for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw .
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