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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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study pre-dating GLP-regulations but giving the relevant details of the study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
abraded and intact skin
Deviations:
yes
Qualifier:
according to guideline
Guideline:
other: Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no
Remarks:
pre-dates GLP-regulation

Test material

Constituent 1
Reference substance name:
ALIZARINLICHTBLAU HRL = Sandolan Blue E-HRL
IUPAC Name:
ALIZARINLICHTBLAU HRL = Sandolan Blue E-HRL
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Irritant / corrosive response data:
None of the animals showed any observable response to treatment throughout the 72 hours observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is considered to be non-irritant to rabbit skin.
Executive summary:

Primary irritation to the skin was measured by a patch test technique on the abraded and intact skin of the albino rabbit, clipped free of hair. A minimum of six subjects were used per skin tests.

Under a square patch such as surgical gauze measuring 1 inch x 1 inch, two single layers thick, 0.5 gram of the test substance were introduced. The test item was moistened with water.

The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animals was then wrapped with an impervious material such as rubberized.cloth for the 24 -hour period of exposure.

After 24 hours exposure, the patches were removed and the resulting reactions were evaluated

None of the animals showed any observable response to treatment throughout the 72 hours observation period

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