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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
6 rabbits; application on intact and and wound skin; observations at 24 and 72 h for erythema and oedema.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and wound
Vehicle:
not specified
Controls:
no
Observation period:
72 h
Number of animals:
6
Details on study design:
OBSERVATION TIME POINTS
24 h and 72 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #3, #4
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 48 h score assumed to be equal to the highest score between 24 and 72 h
Irritation parameter:
erythema score
Basis:
animal: #2, #5, #6
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 48 h score assumed to be equal to the highest score between 24 and 72 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: 48 h score assumed to be equal to the highest score between 24 and 72 h

Any other information on results incl. tables

animal skin erythema oedema
24 h  72 h 24 h 72 h
#1 intact 2 0 1 0
wound 2 1 2 1
#2 intact 1 0 1 0
wound 1 0 1 0
#3 intact 2 0 1 0
wound 2 0 2 0
#4 intact 2 0 1 0
wound 2 0 2 0
#5 intact 1 0 1 0
wound 2 0 2 1
#6 intact 1 0 1 0
wound 1 0 2 1

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritant to rabbit skin.
Executive summary:

Method

Test substance was applied on intact and wound skin of 6 rabbits; observations for erythema and oedema were done at 24 and 72 h.

Results

Signs of irritation on intact skin were noted at 24 h and were fully reversible within the 72 h observation period. Signs of irritation on wound skin were not completely reversible within the 72 h observation period; however they showed a clear tendency to decrease.