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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

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:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
0.5 ml under gauze dressing to the clipped intact skin of adult albino rabbits for a period of 4 hr with observations for erythema and edma at 4, 24, 48 and 72 hr. Score of 5 or more is considered a primary irritant.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Ken-React KR TTS
Lot R-1082S

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hr.
Observation period:
4, 24, 48 and 72 hr
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.3
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Remarks on result:
no indication of irritation
Other effects:
Non observed

Any other information on results incl. tables

E

   Erythema & Eschar          
 Animal #  1  2  3  4  5  6
 4 hr  1  1  1  1  1
 24 hr  1  1  1  0  0  0
 48 hr  0  0  0  0  0  0
 72 hr  0  0  0  0  0  0

Edema score

0 for animals during the test.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The target substance is not irritating to skin with irritation score of 0.3.