Registration Dossier
Registration Dossier
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EC number: 268-581-5 | CAS number: 68130-24-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- December 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Final report summary
- Deviations:
- yes
- Principles of method if other than guideline:
- - Principle of test:
Acute Oral Toxicity
- Short description of test conditions: 10 (5M, 5F) albino rats, each received a single dose of the test article at a dose level of 5 g/kg bw.
- Parameters analysed / observed: Animals were observed for pharmacologic activity and drug toxicity 1, 3, 6 and 24 hours after treatment, and daily thereafter for a total of 14 days. - GLP compliance:
- not specified
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- EC Number:
- 268-581-5
- EC Name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- Cas Number:
- 68130-24-5
- Molecular formula:
- C10-H22-O7.x-C10-H20-O2.x-C8-H16-O2.x-C5-H10-O2
- IUPAC Name:
- Decanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] octanoate pentanoate
- Test material form:
- liquid
- Details on test material:
- - Moisture content:<= 0.05 %
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot P-612J4
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 Male and 5 Female albino rats, 200-266 g, each received a single oral dose of the test article at a dose level of 5 g/kg bw
Administration / exposure
- Route of administration:
- oral: unspecified
- Doses:
- 5 g/kg bw
- No. of animals per sex per dose:
- 5 Male and 5 Female
- Control animals:
- yes
- Details on study design:
- Animals were observed for pharmocologic activity and drug toxicity 1,3,6, and 24 hours after treatment, and daily thereafter fro a total of 14 days.
Non-survivors and animals surviiving the 14 day observation period were subjected to gross necropsy, with all findings noted.
No mortality was observed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- none
Applicant's summary and conclusion
- Conclusions:
- LD50 > 5 g/kg
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