6,9,10-trimethylundeca-3,5,9-trien-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Principles of method if other than guideline:

-

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,9,10-trimethylundeca-3,5,9-trien-2-one

EC Number:

211-450-4

EC Name:

6,9,10-trimethylundeca-3,5,9-trien-2-one

Cas Number:

645-68-1

Molecular formula:

C14H22O

IUPAC Name:

(3E,5E)-6,9,10-trimethylundeca-3,5,9-trien-2-one

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

500, 2000 mg/kg bw (range finding test)
2000 mg/kg bw (main test)

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Any other information on results incl. tables

--

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The purpose of this study was to assess the acute oral toxicity of the test article, Pseudoiron, in the rat using the Fixed Dose Method. Since the results of the range finding study indicated that a dose level of 2000mg/kg produced no mortality, in the main study, the test article was administered at this dose level as a single oral dose to a group of 5 male and 5 female rats which had been fasted overnight. The animals were examined frequently on the day of dosing and daily thereafter for a further 14 days at the end of which, they were killed and subjected to necropsy. When the test article was administered in the main study at a dose level of 2000mg/kg no deaths occurred and there were no clinical signs of toxicity throughout the observation period. There was no adverse effect on body weight gain in animals of either sex. No abnormalities were detected in any animal at necropsy. Treatment with the test article, Pseudoiron, at a dose level of 2000mg/kg bodyweight produced no deaths or clinical signs of toxicity. The results of this study indicate that the maximum tolerated oral dose is greater than 2000mg/kg bodyweight.