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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-534-7 | CAS number: 122-32-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Feb 1988 - 09 Mar 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted in 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- adopted in 1984
- Deviations:
- yes
- Remarks:
- a limit dose level of 2000 mg/kg bw was applied.
- Qualifier:
- according to guideline
- Guideline:
- other: Bewertung Wassergefährdender Stoffe, II Bestimmung der akuten, oralen Säugertiertoxizität, Ad hoc Arbeitsgruppe I, LTwS, nr. 10 September 1979
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1,2,3-propanetriyl trioleate
- EC Number:
- 204-534-7
- EC Name:
- 1,2,3-propanetriyl trioleate
- Cas Number:
- 122-32-7
- Molecular formula:
- C57H104O6
- IUPAC Name:
- 1,2,3-propanetriyl trioleate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
-Chemical name: Glycerol trioleate
- Physical state: liquid
- Analytical purity: approx. 100% ester
- Stability under test conditions: stable at storage conditions
- Storage condition of test material: at ambient temperature in the dark
- Specific gravity: 0.92 g/mL (20 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 222 ± 3.6 g (males), 177 ± 7.5 g (females)
- Fasting period before study: animals were fasted overnight (prior to dosing) until approx. 3 h after administration of the test substance.
- Housing: individually housed in polycarbonate cages containing purified sawdust (Woody Clean supplied by Broekman Institute, Someren, The Netherlands) as bedding material.
- Diet: standard pelleted laboratory animal diet (RMH-B, Hope Frams, Woerde, The Netherlands), ad libitum.
- Water: tap-water (via automatic nozzles), ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%): 50-60
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 22 Feb 1988 To: 09 Mar 1988
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: the dose volume (mL/kg bw) used was calculated as follows:
dose (g/kg bw) / specific gravity (g/mL)
The specific gravity used was 0.92 g/mL. Thus the maximum dose volume applied was 2.174 mL/kg bw. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on the day of dosing (approx. once every 2 h) and once daily thereafter for 14 days. Any signs of toxicity were recorded along with the time of onset and duration. Individual body weights were measured weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the 14-day observation period.
- Clinical signs:
- other: No signs of systemic toxicity were observed during the 14-day observation period.
- Gross pathology:
- Macroscopic examination of animals at termination did not reveal any abnormalities that were considered to be treatment-related.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
