Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The method followed that described in the OECD Guidelines for Testing of Chemicals, Updated Guideline No 429 Skin Sensitisation LLNA (adopted 24 April 2002)

Data source

Reference
Reference Type:
publication
Title:
Identification of metal allergens in the local lymph node assay
Author:
Basketter, D. A. Lea, L. J. Cooper, K. J. Ryan, C. A. Gerberick, G. F. Dearman, R. J. Kimber, I.
Year:
1999
Bibliographic source:
American Journal of Contact Dermatitis 1999, 10, (4), 207-12.

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
none
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical Name: Lead Acetate
Supplier: Sigma

Vehicle: DMSO

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Harlan Olac
Bicester, UK


- Age at study initiation:
7 - 12 weeks (beginning of treatment)

- Weight at study initiation:
no details given

- Housing:
no details given

- Diet (e.g. ad libitum):
no details given

- Water (e.g. ad libitum):
no details given

- Acclimation period:
no details given

ENVIRONMENTAL CONDITIONS
no details given

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
2.5, 5, 10 %
No. of animals per dose:
Total 16 animals
3 test groups with 4 animals
1 control group with 4 animals
Details on study design:
according to guideline
Positive control substance(s):
other: Gold III chloride

Results and discussion

Positive control results:
Substance: Gold III chloride
Vehicle: DMSO
concentration (wt-%) , SI
5 , 21.8
10, 10.9
25, 17.2

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
Concentration SI Vehicle 1.0 2.5 % lead acetate 0.7 5 % lead acetate 0.8 10 % lead acetate 1.0

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The experimental data show that lead diacetate is not a skin sensitizer in mice and would not be expected to be a skin sensitizer in humans.
It is reasonable to assume that the skin sensitising property of lead salts is triggered by the lead cation and not the corresponding anion. Therefore, it is considered justified to use data from lead diacetate also for other soluble lead salts like lead acetate. Consequently, lead acetate is not considered to be a skin sensitiser.
Executive summary:

In the study the test item dissolved in DMSO was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay was performed using test item concentrations of 2.5, 5, and 10%. In this study Stimulation Indices (S.I.) of 0.7, 0.8, and 1.0 were determined with the test item at concentrations of 2.5, 5, and 10% in DMSO, respectively.

The test item was not a skin sensitizer in this assay.