Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-847-0 | CAS number: -
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:
- guideline study with acceptable restrictions
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See attachment
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See attachment
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- 1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See attachment
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See attachment - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
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:
- Tetradecanol
- EC Number:
- 204-000-3
- EC Name:
- Tetradecanol
- Cas Number:
- 112-72-1
- Molecular formula:
- C14H30O
- IUPAC Name:
- tetradecan-1-ol
- Reference substance name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
- Molecular formula:
- C20H38O5
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
- Reference substance name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
- Molecular formula:
- C23H42O7
- IUPAC Name:
- Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
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
- Key result
- 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 Reaction products of tetradecan-1-ol and L-(+)-lactic acid for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
