Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study, that generally meets accepted scientific principles sufficient for an assessment

Data source

Reference
Reference Type:
publication
Title:
Dermal irritancy of metal compounds. Studies with palladium, platinum, lead, and manganese compounds.
Author:
Campbell, K. I.; George, E. L.; Hall, L. L.; Stara, J. F.
Year:
1975
Bibliographic source:
Archives of Environmental Health 1975, 30, (4), 168-70.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details provided

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and unchanged sites
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 g/ml
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
- 6 healthy albino rabbits 2-3 kg
- seven pairs of 2x2 cm sites clipped
- right side abraded, left side unchanged
- application of test material
- coverage with gauze patch secured with tape and a leather restraining harness
- after 24 hours removing of the coverings, followed by washing and gently rinsing/drying
- evaluation and scoring at 24 h and again 48 hours later

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Remarks on result:
other: intact skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Remarks on result:
other: intact skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No skin irritating potential could be detected. According to 67/548/EC and CLP the test material should not be classified as a skin irritant.
Executive summary:

0.1 g of the test material was mixed with several drops of Aqua pro injectione to ensure good skin contact. The test with five animals showed no signs of irritation at the treated areas following single application to the intact dorsal skin of rabbits for 24 hours under occlusive conditions.

Under the conditions of the present study no signs of skin irritation were seen. Similar results would be expected for lead acetate and lead diacetate.