Dexpanthenol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data are given, equivalent or similar to OECD guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

BASF-Test.
In principle, the methods described in OCED guideline 401 were used.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

D-Panthenol

IUPAC Name:

D-Panthenol

Constituent 2

Reference substance name:

Dexpanthenol

EC Number:

201-327-3

EC Name:

Dexpanthenol

Cas Number:

81-13-0

Molecular formula:

C9H19NO4

IUPAC Name:

2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
male and female rats
- Age at study initiation: young adult, no further data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
distilled water
- Concentration in vehicle: 46.4 - 50% (w/v)
- Amount of vehicle: 10 mL/kg bw
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

up to 10000 mg/kg bw; no further details

No. of animals per sex per dose:

5-10/sex/group; no further data

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: In the highest dose group (10000 mg/kg bw), impaired general state with unspecific symptoms was noted at the first day of the study. No other findings were observed.

Gross pathology:

No pathological findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item revealed an acute oral LD50 greater than 10000 mg/kg bw in rats.

Executive summary:

The LD50 was > 10000 mg/kg bw.

Groups of male and female rats were administered the test substance by gavage as an aqueous solution at doses of up to 10000 mg/kg bw and were observed for 14 days. No deaths were observed. Clinical signs of toxicity were limited to impaired general state with unspecific symptoms observed at the highest dose level at the day after dosing only. Pathology revealed no abnormal findings.