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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
Study period:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
Barail-Test:
intracutaneous injection of an aqueous solution (1) or application on depilated skin (2)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Reactive Red 23

Test animals

Species:
rabbit
Strain:
other: Silver Yellow
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: one per cage
- Diet: Altromin standard diet ad libitum
- Water: mains water ad libitum

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
(1) injection of 0.02mL of 10, 1, 0.1 and 0.01% test item in water
(2) application of 0.5mL of 10% test item in water on depilated skin
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no irritant effects were observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test substance is determined as not irritating to rabbit skin.