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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Detection of contact sensitivity of metal salts using the murine local lymph node assay
Author:
Yoshiaki Ikarashi et.al
Year:
1992
Bibliographic source:
Toxicology Letters, 1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Principles of method if other than guideline:
LLNA was performed to evaluate the contact sensitivity of the test chemical
GLP compliance:
not specified
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Manganese dichloride
EC Number:
231-869-6
EC Name:
Manganese dichloride
Cas Number:
7773-01-5
Molecular formula:
Cl2Mn
IUPAC Name:
Manganese chloride
Test material form:
solid: crystalline
Details on test material:
Name of the test chemical: Manganese chloride
Molecular Weight: 125.844 g/mol
Molecular Formula: MnCl2
Substance Type: Inorganic
Physical State: Solid

In vivo test system

Test animals

Species:
mouse
Strain:
Balb/c
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Japan SLC Inc., Shizuoka, Japan),
- Age at study initiation: 6-8 weeks old

Study design: in vivo (LLNA)

Vehicle:
other: 20% ethanol
Concentration:
25 microliters of 10% test chemical
No. of animals per dose:
3
Details on study design:
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of mice (n=3) were treated with the indicated concentrations of metal salts or vehicle (20% ethanol
solution) by applying 25microliters to the dorsum of both ears for three consecutive days. Prior to the test chemicals
treatment, the ears of each mouse were gently abraded using a 19-g needle. Four days following the initial application, draining lymph nodes were excised. A single cell suspension of LNC was prepared and incorporation of [3H]TdR was measured.
Positive control substance(s):
not specified
Statistics:
The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per min (cpm) + standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated for each test group and expressed as stimulation indices (SI).

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Value:
0.82
Test group / Remarks:
test group
Remarks on result:
other: no reactions observed
Cellular proliferation data / Observations:
CELLULAR PROLIFERATION DATA/observation

CELLULAR PROLIFERATION DATA: [3H]TdR incorporation
(mean cpm ± SD (x 10-3)) = 1.26 + 0.08

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
The SI value of the test chemical was 0.82. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical was considered to be not sensitizing to skin
Executive summary:

LLNA was performed to evaluate the contact sensitivity of the test chemical.

Groups of female BALB/c mice (n=3) were treated with 10% of the test chemical in 20% ethanol or ethanol alone by applying 25 microliters to the dorsum of both ears for three consecutive days. Four days following the initial application, draining lymph nodes were excised. A single cell suspension of LNC was prepared. Incorporation of [3H]TdR was measured, and recorded as mean cpm ± standard deviation (SD) per node of three mice for each group.The incorporation of [3H]TdR was measured using a liquid scintillation counter and expressed as mean counts per

min (cpm) + standard deviation per node of three animals for each test group. Increases in [3H]TdR incorporation relative to vehicle-treated controls were calculated

for each test group and expressed as stimulation indices (SI).                          

The SI value of the test chemical was 0.82. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical as considered to be not sensitizing to skin