Iron tris(phosphinate)

Endpoint summary

Description of key information

Skin Sensitization:

Based on the available data for the structurally similar read across 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 irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Remarks:

in vivo

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 closely related chemicals

Justification for type of information:

Weight of evidence approach based on closely related 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 closely related chemicals

Principles of method if other than guideline:

Weight of evidence approach based on closely related chemicals

GLP compliance:

not specified

Type of study:

other: Weight of evidence approach based on closely related chemicals

Specific details on test material used for the study:

- Name of test material: Ferric hypophosphite
- IUPAC name: iron(3+) ion triphosphinate
- Molecular formula: FeO6P3
- Molecular weight: 250.8084 g/mole
- Smiles : [Fe+3].[O-]P=O.[O-]P=O.[O-]P=O
- Inchl: 1S/Fe.3H3O2P/c;3*1-3-2/h;3*3H2,(H,1,2)/q+3;;;/p-3
- Substance type: Inorganic
- Physical state: Solid powder (white to grey)

Species:

other: guinea pigs and humans

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data available

No. of animals per dose:

Weight of evidence approach based on closely related chemicals

Details on study design:

This study is based on the Weight of evidence approach based on closely related chemicals

Challenge controls:

Weight of evidence approach based on closely related chemicals

Positive control substance(s):

not specified

Vehicle:

not specified

Concentration:

Weight of evidence approach based on closely related chemicals

No. of animals per dose:

Weight of evidence approach based on closely related chemicals

Details on study design:

This study is based on the Weight of evidence approach based on closely related chemicals

Statistics:

This study is based on the Weight of evidence approach based on closely related chemicals

Reading:

other: This study is based on the Weight of evidence approach based on closely related chemicals

Group:

test chemical

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Cellular proliferation data / Observations:

This study is based on the Weight of evidence approach based on closely related chemicals

Interpretation of results:

other: not sensitizing

Conclusions:

On the basis of available studies for the closely related substances, the weight of evidence approach was applied to assess the dermal sensitization potential for target substance.
Ferric hypophosphite was estimated to be not sensitizing to skin.

Executive summary:

Based on the available studies for the closely related chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Ferric hypophosphite.

 

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

Groups of female BALB/c mice (n=3) were treated with 5% of the test chemical in DMSO or DMSO 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 1.15. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical was considered to be not sensitizing to skin.

 

This is supported by a case study reported for a 52-year-old female patient was seen in the surgical ward after an operation developed itching and eruption on her abdomen with 48 hours of operation. The eruption spread to the areas beyond the bandage on her abdomen; rather ill-defined patches of erythema, papules, vesicles and erosions were observed. It was diagnosed as contact eczema. The patient was patch tested with all the ointments which were in contact with skin. Later it was deduced that ethanol. So a series of patch tests were performed on series of alcohols, aldehydes, ketones as well impurities present in alcohol to determine the contact sensitization potential.

2% solution of the test chemical in water did not cause any dermal sensitization.

Hence, the test chemical can be 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:

Based on the available studies for the closely related chemicals, weight of evidence approach was applied to assess the dermal sensitization potential of Ferric hypophosphite.

 

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

Groups of female BALB/c mice (n=3) were treated with 5% of the test chemical in DMSO or DMSO 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 1.15. Since the SI value was below 3, EC3 value couldnot be calculated. Hence, the test chemical was considered to be not sensitizing to skin.

This is supported by a case study reported for a 52-year-old female patient was seen in the surgical ward after an operation developed itching and eruption on her abdomen with 48 hours of operation. The eruption spread to the areas beyond the bandage on her abdomen; rather ill-defined patches of erythema, papules, vesicles and erosions were observed. It was diagnosed as contact eczema. The patient was patch tested with all the ointments which were in contact with skin. Later it was deduced that ethanol. So a series of patch tests were performed on series of alcohols, aldehydes, ketones as well impurities present in alcohol to determine the contact sensitization potential.

2% solution of the test chemical in water did not cause any dermal sensitization.

Hence, the test chemical can be 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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

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.