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Registration Dossier
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EC number: 271-692-1 | CAS number: 68604-41-1 The complex residuum from the distillation of the methyl ester of C16-18 and C18-unsatd. fatty acids. It consists primarily of trialkyl glycerides and undistilled methyl ester of the fatty acids.
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From March 12,1980 to Jun4 04,1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP and some minor details missing, but well described and compliant with official guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- IUPAC Name:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. Residues
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Constituent 1
- Specific details on test material used for the study:
- Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues- Physical state: black , brown semisolid- Analytical purity:100% - Storage condition of test material: room temperature- Solubility: < 10% in water, soluble in acetone, hexane and dichloromethane
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals (Wistar. MuRa Han 67 SPF) were adapted 8 days from the arrival. Their age was for males 29-30 days, for females 23-24 days. Their weight was 129 g for males, 119 g for femails.They were caged in groups of 2-3 for cage. Room temperature of 21+2°C. 12hours light and 12 hours night. Food and water was provided ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 12 weeks
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:250 mg/kg/dayBasis:actual ingested
- No. of animals per sex per dose:
- 20+10 animals per sex per dose
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- Urine: pH, albumine, Glucose, Urobilinogen, Keton corps, density, Blood, sedimentsBlood: Emoglobine, Ematocrite, Cell volume, Number of eritrocytes, Number of Leucocytes, microscopical evaluationBiochemistry: Sodium and postassium, Glucose, Minerals, GOT, GPT
- Sacrifice and pathology:
- After the testing period all animals were sacrificed and analysed for histopathology
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The substance showed no treatment related effect at the tested dose
- Executive summary:
Nach wiederholten oralen Gaben von 250 mg das Prüfstoffes/kg KG/Arbeitstag führt die Substanz an Ratten zu den hämatologischen,
urologischen und biochemischen Befunden, die als zufällig, interindividuell spezifsch und im Rahmenberaich dar biologischen
Streubreiten liegend, gedautet warden können. Die wiaderholte orale Applikation der obigen Dosis ist demnach als dia für Ratten nicht kumulativ schädigende tägliche Gabe einzustufen.
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