Dexpanthenol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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 403 (Acute Inhalation Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

The study was carried out in accordance with Smyth HF et al (1962). Am Ind Hyg Ass J 23: 95-107.
In principle, the methods described in OCED guideline 403 were used.

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

other: Inhalation Risk Test

Limit test:

yes

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:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

atmosphere saturated with vapours of the test substance, no further data

No. of animals per sex per dose:

totally 6 males and 6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: before the start of the study and at the end of the observation period
- 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:

LC50

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

other: No death were observed during a 7 h-inhalation period of the test animals in a saturated atmosphere at room temperature. As the saturation vapour pressure is very low (less than 0.001 Pa at 20 °C), no exact concentration estimation could be performed..

Mortality:

No mortality was observed when 12 rats were exposed for 7 hours to an atmosphere that had been saturated at 20°C with the volatile parts of the compound.

Clinical signs:

other: No clinical signs of toxicity were observed.

Body weight:

no data

Gross pathology:

No abnormal findings were reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No death were observed during a 7 h-inhalation exposure of rats to a saturated atmosphere of the test item at room temperature.

Executive summary:

In an acute inhalation toxicity study, one group of 12 rats (6/sex) was exposed for 7 h to a saturated atmosphere of D-Panthenol at 20°C. Animals then were observed for 14 days. No mortality occurred. No clinical signs of toxicity. were observed. No gross pathological findings were reported.