Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
testing lab.
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
EC Number:
600-026-8
Cas Number:
1000817-22-0
Molecular formula:
Unspecified
IUPAC Name:
Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
Details on test material:
Name of test substance: Kerocom FM 38
Batch identification: 2008250
Purity: 100% (safety data sheet)
Homogeneity: The test substance was homogeneous by visual inspection.
Storage stability: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Storage conditions: Room temperature
Physical state/ color: Liquid/ yellow to brownish, clear
Density [g/mL]: 0.961 (determined by Bioassay)

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Age on day 0: Young adult animals (female animals approx. 10 weeks)
Sex: As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test substance.
Supplier: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Arrival in the testing facility: Acclimatization period at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
Identification: Individual identification by cage cards and tail marking.
Body weight on day 0: Animals of comparable weight.

Room temperature/relative humidity: The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for temperature and of 20 – 80% for relative humidity. Day/night rhythm: 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)
Type of cage: Makrolon cage, type III
Number of animals per cage: single housing
Feeding: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
Drinking water: Tap water ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
For the high dose, the liquid test substance was administered unchanged. For the lower dose, an administration volume of 2 ml/kg of suitable test substance preparations was used to facilitate application.
The test-substance preparations of the 300 mg/kg test groups were produced shortly before the administrations by stirring with a magnetic stirrer.
Solution in Olive oil Ph.Eur.
Form of administration: 300 mg/kg: Solution; 2000 mg/kg: Undiluted
The stability of the test substance in the vehicle will be determined indirectly by the concentration control analysis by the sponsor. For this purpose, the sample taken was stored at room temperature over the maximum duration of the administration period and was subsequently deep-frozen and was sent to the sponsor for analysis.
The homogeneity of the test-substance preparation in the vehicle will be not determined by analysis because the test-substance preparation was a solution.
A concentration control analysis of the test-substance preparation will be done in the sample which was sent to the sponsor.
Doses:
300, 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays, these records are archived by Bioassay.
Necropsy with gross-pathology examination on the last day of the observation period after sacrificed by CO2-inhalation in a chamber with increasing concentrations over time.
No histological examinations were performed.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred in the nine females administered 2000 or 300 mg/kg bw (2000 mg/kg in 6 females, 300 mg/kg in 3 females).
Clinical signs:
No clinical signs and findings were observed in the 2000 and 300 mg/kg bw administration groups.
Body weight:
The mean body weights of the test groups increased normally throughout the study period.
Gross pathology:
There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion