Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted accorrding OECD protocols and GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Fatty acids, C10-20-neo-
EC Number:
285-549-6
EC Name:
Fatty acids, C10-20-neo-
Cas Number:
85116-96-7
Molecular formula:
C10H20O2 ... C20H40O2
IUPAC Name:
C10-20-neo-Fatty acids
Details on test material:
- Name of test material (as cited in study report): Versatic 1019
- Substance type: brown liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
maize oil
Doses:
2000 mg/kg
No. of animals per sex per dose:
15 per sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the study conditions VERSATIC 1019 has an LD50 of >2000 mg/kg
Executive summary:

In this study, male and female rats were gavage with VERSATIC 1019 at concentrations of 2000 mg/kg. Based on the results, it is concluded that the LD50 is >2000 mg/kg.