Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
24 hours
Effect level:
> 10 mL/kg bw
Based on:
test mat.
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
Body weight:
The animals of the upper dosage goups did not show clear differences in weight gains compared to the lower dosage, weight gains did lay in normal ranges.

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).