1-propoxypropan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP study equivalent to OECD guideline 404

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-propoxypropan-2-ol

EC Number:

216-372-4

EC Name:

1-propoxypropan-2-ol

Cas Number:

1569-01-3

Molecular formula:

C6H14O2

IUPAC Name:

1-propoxypropan-2-ol

Details on test material:

Name of test material (as cited in study report): PROPASOL Solvent P
- Physical state: clear, non-viscous liquid
- Lot/batch No.: #3251; S-066890

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): pure substance (100%)

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

6 (3 males & 3 females)

Details on study design:

TEST SITE
- Type of wrap if used: gauze patch loosely covered with impervious sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): excess sample was removed after contact
- Time after start of exposure: 4h

SCORING SYSTEM: skin reaction is scored by the method of Draize (see table below)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

over all animals

Time point:

other: 24, 48 and 72 hours

Score:

0.9

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

over all animals

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Minor to moderate erythema on 4 of 6 rabbits, minor edema on 3 from 0.5 ml; no irritation, except desquamation, after 7 days

Other effects:

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The application of 0.5 ml PROPASOL Solvent P to occluded rabbit skin resulted in mean irritation scores of 0.9 (erythema) and 0.4 (edema); fully reversible within 7 days. Therefore, it can be concluded that PROPASOL Solvent P is not irritating according to EU classification.

Executive summary:

Three male and three female New Zealand White rabbits were dosed with 0.5 ml PROPASOL Solvent P. The dose was applied to the clipped, intact skin under a gauze patch and was loosely covered with impervious sheeting. The test material was applied to each of 6 rabbits, which were restrained for the 4 -hour contact period. Excess sample was removed after contact. Skin reaction was scored by the method of Draize at one hour, one day, 2 days, 3 days, 7 days, 10 days and 14 days after dosing. The 4-hour application of PROPASOL Solvent P to occluded rabbit skin resulted in minor to moderate erythema on 4 of 6 rabbits and minor edema on 3. After 7 days, half of the rabbits developed desquamation, but no other irritation was evident. By 14 days there was desquamation on only one animal.