Propane-1,3-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Reliability assigned by ACC in HPV Document

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Guideline:

other: Guideline not reported in secondary source

Principles of method if other than guideline:

Undiluted test substance was applied to the shaved dorso-lumbar skin of two rats/sex/group. A bandage was applied to the region using an impermeable dressing of aluminum foil and waterproof plaster. After 24 hours, the bandage was removed, and the area washed with a tepid dilute detergent solution. Rats were deprived of food during the 24-hour exposure. The animals were observed for signs of toxicity over the following 9 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propane-1,3-diol

EC Number:

207-997-3

EC Name:

Propane-1,3-diol

Cas Number:

504-63-2

Molecular formula:

C3H8O2

IUPAC Name:

propane-1,3-diol

Details on test material:

- Purity: Not reported

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Fasted during exposure
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

1.0, 2.0, or 4.0 mg/kg

No. of animals per sex per dose:

2/sex/group

Control animals:

no

Details on study design:

Undiluted test substance was applied to the shaved dorso-lumbar skin of two rats/sex/group. A bandage was applied to the region using an impermeable dressing of aluminum foil and waterproof plaster. After 24 hours, the bandage was removed and the area washed with a tepid dilute detergent solution. Rats were deprived of food during the 24-hour exposure. The animals were observed for signs of toxicity over the following 9 days.

Results and discussion

Effect levels

Dose descriptor:

LD50

Effect level:

> 4 200 mg/kg bw

Remarks on result:

other: LD50 was determined to be > 4 mL/kg which was equivalent to > 4200 mg/kg.

Mortality:

No deaths occurred prior to scheduled sacrifice.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 (rat): >4200 mg/kg

Executive summary:

Undiluted test substance was applied to the shaved dorso-lumbar skin of two rats/sex/group at concentrations of 1.0, 2.0, or 4.0 mL/kg. After 24 hours, the bandage was removed and the area washed with a tepid dilute detergent solution. The animals were observed for signs of toxicity over the following 9 days.  The LD50 was determined to be > 4 mL/kg which was equivalent to > 4200 mg/kg.