4-((3-acetoxypropyl)amino)-2,2-dimethyl-4-oxobutane-1,3-diyl diacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate

Cas Number:

98133-47-2

Molecular formula:

C15H25NO7

IUPAC Name:

3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate

Test material form:

liquid: viscous

Specific details on test material used for the study:

The compound PANTHENYLTRIACETAT was delievred by Induchem AG, CH-8600 Dübendorf. The compound was a clear, slight viscouns liquid in a metal bottle with the inscription: D-Panthenyltriacetat (100% ig/ein Derivat von Panthenol, Vitamin B5).

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

For this study SPF-Wistarrats (strain Winkelmann, Paderborn) were used with mean body weights of 210 g.
The animals were kept in groups of 5 males and 5 females "at random" divided in single cages.
They were fed with a laboratory standard diet (Altromin, Lage, s.Appredix) and watered ad libitum. The room temperature was kept constantly at 22°C +/- 2°C, the relative atmospheric humidity 50-60 p.c and daily time of illumination 12 hours.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

For testprocedure compound was warmed till 35°C and had been applicated orally by a nonflexible stomach tube.

Doses:

The animals of group I recieved 0.5 mL per 100 g body-weight, animals of group II got 1 mL per 100 g body-weight.

No. of animals per sex per dose:

Group n (Sex) Dosage Concentration
I - 5 males, 5 females 5mL/Kg - BW Undiluted
II 5 males, 5 females 10 mL/Kg .- BW Undiluted

Control animals:

not specified

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

24 hours

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Remarks:

14 days

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Mortality:

No mortality occured

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Compound had been tested up to maximal dosage of 10 mL/Kg- BW.
Weight gains did not point out any signs of incompatibility
Clinical picture did not show any diviations to normal findings
Macroscopical aspection after 14 days did also not point to antomical pathological changes
Compound PANTHENYLTRIACETAT with a single oral gavage to rats can be considered as harmless (Practical nontoxic).