Registration Dossier
Registration Dossier
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EC number: 248-315-4 | CAS number: 27194-74-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 January 2016 - 16 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Lauric acid, monoester with propane-1,2-diol
- EC Number:
- 248-315-4
- EC Name:
- Lauric acid, monoester with propane-1,2-diol
- Cas Number:
- 27194-74-7
- Molecular formula:
- C15H30O3
- IUPAC Name:
- 1-hydroxypropan-2-yl dodecanoate; 2-hydroxypropyl dodecanoate
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: liquid
Constituent 1
- Specific details on test material used for the study:
- Physical state/Appearance: clear colorless liquid
Batch: 1023R26015
Purity: 100%
Expiry Date: 14 September 2019
Storage Conditions: room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Arachis oil for the 300 mg/kg dose level.
- Doses:
- 300 mg/kg body weight and 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 300 mg/kg body weight: 1
2000 mg/kg bod weight: 5 - Control animals:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified).
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.
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