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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test: Two animals were treated for 1, 5 and 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min) the skin was washed with Lutrol (50%). The animals were observed for 14 days and skin changes were recorded daily.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: unchanged or olive oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): undiluted or as 30% solution in olive oil

Duration of treatment / exposure:
1, 5 and 15 min
Observation period:
14 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: skin was washed with Lutrol (conc.) and Lutrol/water (1:1).
- Time after start of exposure: After the 1, 5 and 15 min exposure time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score for undiluted test substance
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score for undiluted test substance
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: score for undiluted test substance
Irritant / corrosive response data:
The test substance, undiluted or as a 30% preparation and applied for 1, 5 or 15 minutes, produced inflammatory erythema followed by desquamation. After application for 15 minutes, slight edema and scaling was observed, additionally. The skin was normal at 14 days after application.

Any other information on results incl. tables

Mean erythema scores (animal 1/2), undiluted test substance:

 Exposure time  same day  24 h  48 h  72 h  8 days  14 days
 1 min 1/1 0/0 0/1 0/2 0/1 0/0
 5 min 2/2 0/1 2/1 1/1 S/1 0/0
 15 min 2/2 2/2 2/2 2/2 S/2 0/0

Mean erythema scores (animal 1/2), 30% dilution of test substance:

 Exposure time  same day  24 h  48 h  72 h  8 days  14 days
 1 min 0/0 0/1 2/1 0/0 S/0 0/0
 5 min 0/0 0/0 2/1 0/0 S/0 0/0
 15 min 0/0 1/0 2/2 1/1 S/S 0/0

S: scales

The original BASF grading was converted into the numerical grading according the OECD Draize system.

The test substance, undiluted or as a 30% preparation and applied for 1, 5 or 15 minutes, produced inflammatory erythema followed by desquamation. After application for 15 minutes, slight edema and scaling was observed, additionally. The skin was normal at 14 days after application.

Applicant's summary and conclusion