Propan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

(1; 5; 15 min and 20 h occlusive exposure, no washing after 20h exposure, 8 day observation period only two animals), study prior to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(1; 5; 15 min and 20 h exposure duration, occlusive exposure, no washing after 20h exposure, 8 day observation period)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propan-1-ol

EC Number:

200-746-9

EC Name:

Propan-1-ol

Cas Number:

71-23-8

Molecular formula:

C3H8O

IUPAC Name:

propan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

Analytical purity: 99.5%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Source: Gaukler
- Body weight at study initiation: 2 males weighing 298 g each

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): 1 ml
- Concentration (if solution): undiluted (concentrated)

Duration of treatment / exposure:

- Dorsal application: 1; 5; 15 min and 20 h
- Ear application: 20 h

Observation period:

8 days (in 24h intervals from day 1-4, then again on day 7 and on day 9

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: back; 2 x 2 cm, ear; 1 x 2 cm

REMOVAL OF TEST SUBSTANCE
- Washing: concentrated Lutrol and 50 % lutrol in water only after exposure for 1, 5, and 15 min

SCORING SYSTEM:
The BASF numerical skin grading system was converted to the scoring system by Draize. Scoring of skin changes was performed as following: day of application, then after 24h, 48h, 72h, 8d.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(15 min exposure)

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24h, 48h, 72h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 15 minutes exposure: Very slight redness was seen in one animal 24 h post application. Redness was no longer present 24h later at the 48h observation time point

Results 2

Irritation parameter:

edema score

Remarks:

(15 min exposure)

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24h, 48h, 72h

Score:

0

Max. score:

4

Remarks on result:

other: 15 minutes exposure

Results 3

Irritation parameter:

erythema score

Remarks:

(20h exposure)

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24h, 48h, 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 hours exposure

Results 4

Irritation parameter:

edema score

Remarks:

(20 h expsoure)

Basis:

mean

Remarks:

(of 2 animals)

Time point:

other: 24h, 48h, 72h

Score:

0

Max. score:

4

Remarks on result:

other: 20 hours exposure: Flaky skin was observed in one of two animals 24h after application. Mild desquamation developed in the same animal by day 7 and was still present on day 9 at termination of the study

Irritant / corrosive response data:

RESULTS IN THE 1 MIN and 5 MIN EXPOSURE GROUPS
- Mean score erythema (2 animals, 24, 48, 72h): 0
- Mean score edema (2 animals, 24, 48, 72h): 0

Other effects:

Body weight at termination: 294 and 296 g, respectively

Any other information on results incl. tables

 Table 1: Summary of Results after 15 mins

Readings	Animal	Erythema	Edema	Further findings
24h	1	0	0
	2	1	0
48h	1	0	0
	2	0	0
72h	1	0	0
	2	0	0
8d	1	0	0
	2	0	0
Mean (24h-72h)	1	0	0
	2	0.33	0
Mean (24h-72h)	All animals	0.17	0

Table 2: Sumary of Results after 20 h

Readings	Animal	Erythema	Edema	Further findings
24h	1	0	0	-
	2	1	0	Flaky skin
48h	1	0	0	-
	2	0	0	-
72h	1	0	0	-
	2	1	0	-
6d	1	0	0	-
	2	1	0	Desquamation
8d	1	0	0	-
	2	0	0	Desquamation
Mean (24h-72h)	1	0	0
	2	0.667	0
Mean (24h-72h)	All animals	0.333	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met