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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:
May 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Food end Drug Adrninistration of the U.S.A in The Federal Register (17 September, 1964 § 191.11)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped (abraded and intact)
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g mixed to a paste in water
Duration of treatment / exposure:
24 hours exposure
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
OBSERVATION TIME POINTS: 24 and 72 hours

SCORING SYSTEM:
-Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

-Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edgestof area well defined by definite raising) 2
Moderate oedema (raised approximately 1 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1#, 2#, 3#, 4#, 5# and 6#
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
animal: 1#, 2#, 3#, 4#, 5# and 6#
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The test material was found to cause no irritation when applied to intact rabbit skin under the conditions of this experiment.
Executive summary:

The substance was tested for skin irritation according to the guideline "Food end Drug Adrninistration of the U.S.A in The Federal Register (17 September, 1964 § 191.11)". Under the conditions of this experiment the test material was found to cause no irritation when applied to intact rabbit skin (erythema and oedema mean values at 24/48/72 h were 0 in all animals).