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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Remarks:
OECD 423
Adequacy of study:
key study
Study period:
22 january 2003 to 29 january 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
as the tested substance is not the registered substance.
Justification for type of information:
As an ingredient for a medical device, tests and protocols established from the O.E.C.D. guideline and International standard NF EN ISO 10993-10 concerning biological evaluation of medical devices are already available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
EC Number:
946-247-6
Molecular formula:
Not relevant for a UVCB substance
IUPAC Name:
Reaction mass of docosanoic acid and icosanoic acid and linoleic acid and linolenic acid and oleic acid and palmitic acid and stearic acid
Test material form:
liquid
Details on test material:
The mixture contains 94.4 % of corn oil oxidised (glycerides, C10-20 and C10-20 unsat, oxidised).
Specific details on test material used for the study:
mixture containing 94.4% of oxidised corn oil

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
used after a 5 to 7 day acclimatisation period. temperature : between 19°C and 22°C , relative hulidity : between 36% and 49%

Administration / exposure

Route of administration:
other: forced feeding
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
force-feeding
Doses:
5.434 mL/kg body weight
No. of animals per sex per dose:
group 1 (control) : 3 male rats and 3 female rats
group 2 (treated) : 3 male rats and 3 female rats
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study.
Body weight:
see table 3 and table 4 of the final attached report (pages 10/16 and 11/16)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
no acute oral toxicity