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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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