Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
01 Jul 1986 - 15 Jul 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance fatty acids, C18-unsatd., dimers (CAS No. 61788-89-4). In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Wistar rats were used, instead of the protocolled Sprague Dawley rats.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pripol 1017
- Physical state: viscous liquid
- Analytical purity: no data
- Composition of test material, percentage of components: fatty acid, C18-unsaturated, dimers 79 %, trimer 19 %, monomer 2 %
- Storage condition of test material: at ambient temperature in the dark
- Other: yellow
- Specific gravity: 0.95 g/ml

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, Brussels, Belgium
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 251-257 g / females: 176-192 g
- Fasting period before study: overnight prior to dosing until 3.5-4 hours after administration
- Housing: individually housed in polycarbonate cages, bedding material (purified sawdust)
- Diet (ad libitum): standard laboratory animal diet (RMH-B, pellet diameter 10 mm)
- Water (ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 60-95
- Photoperiod (hrs dark / hrs light): 12 / 12


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Test article was administered as a single dose using a stainless steel stomach cannula. The dose volume was: dosis (g)/specific gravity. The specific gravity used was 0.95 g/mL.
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
Cage-side observations were performed on the day of dosing (approximately once every two hours) and daily thereafter. With exception of weekends and holidays a mortality check was performed at the end of the day. Individual body weights (with group means and standard deviation) were measured weekly. At the end of the study (day 14) all surviving animals were sacrificed by CO2-asphyxiation and subjected to gross necropsy.
Statistics:
The LD50 value is calculated from the observed mortality data, using any established statistical procedure, e.g. that of Litchfield and Wilcoxon (1949), Weil (1952) or Finney (1971).

Results and discussion

Preliminary study:
In order to establish an appropriate dose range three groups of animals, each comprising 1 male and 1 female, were dosed with a single oral dose of the test substance at 560, 1000, 1800, 3200 and 5000 mg/kg body weight, respectively. No mortalities occurred and no signs of systemic toxicity were observed during the 7-day observation period.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortalities occurred.
Clinical signs:
No signs of systemic toxicity were observed during the 14-day observation period.
Body weight:
Weekly group mean body weight increased within the normal range. There was no evident sex related effect.
Gross pathology:
Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities.

Any other information on results incl. tables

Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification