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Diss Factsheets

Administrative data

Description of key information

Skin Sensitization:

On the basis of available studies for the closely related chemicals, the weight of evidence approach was applied to assess the skin sensitization potential for target substance. Manganese(2+) bis(phosphinate) was estimated to be not sensitizing to skin

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Weight of evidence approach based on similar chemicals
Justification for type of information:
Weight of evidence approach based on similar chemicals
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
other: Weight of evidence approach based on similar chemicals
Principles of method if other than guideline:
The weight of evidence report has been prepared based on the read across substances identified based on structural and functional similarity to assess the dermal sensitization potential of manganese(2+) bis(phosphinate)
GLP compliance:
not specified
Type of study:
other: Weight of evidence approach based on similar chemicals
Specific details on test material used for the study:
- Name of test material: manganese(2+) bis(phosphinate)
- Molecular formula: H3O2P1/2Mn
- Molecular weight: 184.9136 g/mol
- Smiles notation: [Mn+2].[O-]P=O.[O-]P=O
- InChl: 1S/Mn.2H3O2P/c;2*1-3-2/h;2*3H2,(H,1,2)/q+2;;/p-2
- Substance type: Inorganic
- Physical state: Solid
Species:
mouse
Strain:
not specified
Sex:
female
Details on test animals and environmental conditions:
no data available
Vehicle:
other: ethanol; propylene glycol
Concentration:
1. 10% of the test chemical in 20% ethanol or ethanol alone by applying 25 microliters
2. 25 μL of the test chemical at 0, 2.5, 5 or 10 % concentrations in propylene glycol
No. of animals per dose:
1. n=3
2. n =4 / dose
Details on study design:
The study is based on weight of evidence approach from the read across values
Positive control substance(s):
not specified
Statistics:
The study is based on weight of evidence approach from the read across values
Parameter:
SI
Value:
> 3
Test group / Remarks:
test group
Remarks on result:
other: not sensitizer
Interpretation of results:
other: not sensitizing
Conclusions:
On the basis of available studies for the closely related chemicals, the weight of evidence approach was applied to assess the skin sensitization potential for target substance. Manganese(2+) bis(phosphinate) was estimated to be not sensitizing to skin
Executive summary:

On the basis of available studies for the closely related chemicals, the weight of evidence approach was applied to assess the dermal sensitization potential for target substance.

LLNA was performed to evaluate the contact sensitivity of the closely related 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.

This result is supported by another LLNA study for otherclosely related chemical.Female CBA mice (n = 4/dose), animals were exposed on the back of the ear to 25 μL of the test chemical at 0, 2.5, 5 or 10 % concentrations in propylene glycol, daily for three consecutive days. Draining lymph nodes were excised from the animals five days after the first dose.                                                                                           

The SI was below three for all doses 1.00, 1.18 and 1.14 for 2.5, 5 and 10 %, respectively. Since the SI values were below 3, EC3 couldnot be calculated, therefore the test chemical was considered to be not sensitizing to skin.

Based on the available data for the closely related substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not sensitizing to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

On the basis of available studies for the closely related chemicals, the weight of evidence approach was applied to assess the dermal sensitization potential for target substance.

LLNA was performed to evaluate the contact sensitivity of theclosely related 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.

This result is supported by another LLNA study for otherclosely related chemical.Female CBA mice (n = 4/dose), animals were exposed on the back of the ear to 25 μL of the test chemical at 0, 2.5, 5 or 10 % concentrations in propylene glycol, daily for three consecutive days. Draining lymph nodes were excised from the animals five days after the first dose.                                                                                           

The SI was below three for all doses 1.00, 1.18 and 1.14 for 2.5, 5 and 10 %, respectively. Since the SI values were below 3, EC3 couldnot be calculated, therefore the test chemical was considered to be not sensitizing to skin.

Based on the available data for the closely related substances and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar manner that of the read across substances. Therefore the target chemical was estimated to be not sensitizing to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

 

 

Justification for classification or non-classification

The results of the experimental studies from the closely related substances indicate a possibility that manganese(2+) bis(phosphinate) can be not sensitizing to skin.

Hence by applying the weight of evidence approach, manganese(2+) bis(phosphinate) can be considered to be not sensitizing to skin. It can be classified under the category “Not Classified” as per CLP regulation.