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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
16 Jun - 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). According 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:
no
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): only trade name given
- Physical state: viscous yellow liquid
- Substance type: UVCB
- Analytical purity: 100%
- 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
- 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: 251 - 257 g (males); 176 - 192 g (females)
- Fasting period before study: overnight
- Housing: animals were individually housed in polycarbonate cages, with purified sawdust as bedding material.
- Diet: standard laboratory animal diet (RMH-B, pellet diameter 10 mm), ad libitum
- Water: tap water, ad libitum
- 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:
MAXIMUM DOSE VOLUME APPLIED: 5.263 mL/kg bw (as calculated from the target dose and specific gravity)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Cage-side observations were done ca. every 2 h on the day of dosing and once daily thereafter. Animals were checked for mortality daily at the end of the day with exception of weekends and holidays. Individual and mean group body weights were determined weekly. All surviving animals were sacrificed by CO2-asphyxiation at the end of the observation period and subjected to gross necropsy.
- Necropsy of survivors performed: yes
Statistics:
If applicable, the LD50 value is calculated from the observed mortality data by means of established statistical methods, such as those described by Lichtfield and Wilcoxon (1949, J. Parmacol. Exp. Ther. 96:99-113), Weil (1952, Biometrics 8:249-263) or Finney (1971, Probit Analysis, 3rd ed., London, Cambridge University Press).

Results and discussion

Preliminary study:
Dose selection was based on a preliminary study in which groups of two animals (1 male and 1 female) were given 560, 1000, 1800, 3200 and 5000 mg/kg bw of the test substance and observed for 7 days. No mortality and no signs of systemic toxicity were observed. Therefore, the limit dose of 5000 mg/kg bw was selected for the main study.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No signs of systemic toxicity were observed during the 14-day observation period.
Body weight:
No abnormalities were observed in weekly group mean body weight gain.
Gross pathology:
No treatment-related gross abnormalities were observed at macroscopic examination.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified