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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study performed according to internationally accepted method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Study was performed to evaluate the potential skin irritant effects of copper slag based on EU B4 method - Acute toxicity - Skin irritation. The tested substance was applied in a single dose on the skin of laboratory animals, using the untreated skin areas as control.
GLP compliance:
no
Remarks:
other quality assurance

Test material

Constituent 1
Reference substance name:
Iron silicate, copper smelting and refining
EC Number:
701-480-0
Cas Number:
67711-92-6
IUPAC Name:
Iron silicate, copper smelting and refining

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Rabbit healthy adult male albino
The diet was standard for these animals. Animal house temperature was maintained at 20 + / - 2c, the relative humidity was between 30 -70% and photoperiod was 12/12 hours light / dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
single dose
Observation period:
24, 48 and 72 hours
Number of animals:
1

Results and discussion

In vivo

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

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This is a good quality study. The sample is not skin irritant
Executive summary:

Study was performed to evaluate the potential skin irritant effects of copper slag based on EU B4 method - Acute toxicity - Skin irritation.

Based on the results, copper slag is not skin irritant. The absence of irritation effects furthermore excludes the possibility of corrosion, defined as a strategic destruction of tissues throughout the skin thickness