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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
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:
1980
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

Constituent 1
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
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/day
Basis:
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, sediments
Blood: Emoglobine, Ematocrite, Cell volume, Number of eritrocytes, Number of Leucocytes, microscopical evaluation
Biochemistry: 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

Key result
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.