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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From 6 to 9 march 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable for the assessment of the endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Remarks:
This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
Single 4 hours application
Observation period:
1, 24, 48 and 72 hours after administration
Number of animals:
3
Details on study design:
SCORING SYSTEM:Primary irritation index / classification- 0: non-irritant- >0-2: mild irritant- >2-5: moderate irritant- >5-8: severe irritant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65954 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65956 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
other: Erythema/eschar formation
Basis:
other: 65957 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65954 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65956 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritation parameter:
edema score
Basis:
other: 65957 male
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Irritant / corrosive response data:
Primary irritation index: 0.0No evidence of skin irritation was noted. Red-coloured staining was noted at two treated skin sites one hour after patch removal.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Executive summary:

A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.10). The method followed OECD Guidelines for Testing of Chemicals (24 April2002) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 671548/EEC). The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.