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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 March 1995 to 07 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C18-unsatd., dimers
Cas Number:
61788-89-4
Molecular formula:
C36H64O4 (representative)
IUPAC Name:
Fatty acids, C18-unsatd., dimers
Constituent 2
Chemical structure
Reference substance name:
Fatty acids, tall-oil
Cas Number:
61790-12-3
Molecular formula:
C18H32O2 (representative)
IUPAC Name:
Fatty acids, tall-oil
Constituent 3
Chemical structure
Reference substance name:
1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
Cas Number:
61791-39-7
Molecular formula:
C22H40N2O (representative)
IUPAC Name:
1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
Test material form:
liquid
Specific details on test material used for the study:
Description: reddish-brown liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
- Test animals approximately 5 weeks of age; 6 weeks old at study start
- Animals were quarantined 9 days prior to test article administration
- Housing: polycarbonate cages
- Diet: Purina Certified Rodent Chow No. 5002
- Water: Tap water, analyzed at least annually

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Single dose
Doses:
2 g/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals observed twice on Test Day 1 approximately 1 and 3 hours following test article administration, and once daily thereafter until necropsy on Day 15.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No adverse signs
Body weight:
Body weights increased for both sexes throughout the study
Gross pathology:
No gross lesions observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the tes material is not toxic to male and female Sprague-Dawley (SD) rats when administered as a single oral dose of 2000 mg/kg
Executive summary:

A single oral dose of 2 g/kg (2000 mg/kg), formulated in corn oil, was administered to a group of five male and five female Sprague-Dawley (SD) rats. All animals of each sex survived until the time of terminal sacrifice on Day 15. No clinical signs of toxicity were noted in any animal and no abnormal findings were noted at necropsy. Based on the results of this study, the test material is not toxic to male and female Sprague-Dawley (SD) rats.