Iron tris(phosphinate)

Endpoint summary

Description of key information

Skin Irritation:

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to skin. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to skin is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be an skin irritant and classified under the category "Category 2" as per CLP.

Eye Irritation:

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to eyes. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to eyes is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be an eye irritant and classified under the category "Category 2" as per CLP.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: 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 based on closely related chemicals

Justification for type of information:

Weight of evidence 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 the closely related chemicals

Principles of method if other than guideline:

Weight of evidence approach based on the closely related chemicals

GLP compliance:

not specified

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:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

Weight of evidence approach based on the closely related chemicalsWeight of evidence approach based on the closely related chemicals

Duration of treatment / exposure:

Weight of evidence approach based on the closely related chemicals

Observation period:

Weight of evidence approach based on the closely related chemicals

Number of animals:

Weight of evidence approach based on the closely related chemicals

Details on study design:

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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

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

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Weight of evidence approach based on the closely related chemicals

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to skin. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7
Hence, the possibility of ferric hypophosphite to cause irritation to skin is quite likely.
Applying the weight of evidence approach, Ferric hypophosphite can considered to be a skin irritant and classified under the category "Category 2" as per CLP.

Executive summary:

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

 

A study was performed to assess the extent of irritation or corrosion caused by test chemical to rabbit skin. The study was performed according to OECD 404 and EC Commission Directive 92/69/EEC, Method B4, Acute Toxicity – Skin irritation.0.5 g of test chemical was applied undiluted to the clipped dorsum skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours. Milli-U water used to moisten the substance to ensure good skin contact. Dermal observations were made for up to 72 hours.

No irritation was observed at any of the treated dermal sites on three rabbits exposed for 4 hours to test chemical. There was no evidence of a corrosive reaction and no indications of dermal staining by the test substance. No mortalities occurred and there were no signs of systemic toxicity recorded.Based on these observations the test chemical can be considered to be not irritating to rabbit skin.

This is supported by a study conducted to determine the extent of irritation or corrosion caused by another closely related test chemical to rabbit skin. The test chemical was applied to back skin of rabbits for one, five, 15 minutes or 20 hours and observed for effects. Exposure to the back skin for 20 hours resulted in slight necrosis, desquamation and scabbing. Hence the test chemical was regarded to be corrosive to rabbit skin.

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to skin. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to skin is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be a skin irritant and classified under the category "Category 2" as per CLP.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: 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 based on closely related chemicals

Justification for type of information:

Weight of evidence based on closely related chemicals

Reason / purpose for cross-reference:

read-across: supporting information

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 based on the closely related chemicals

Principles of method if other than guideline:

Weight of evidence based on the closely related chemicals

GLP compliance:

not specified

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:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

Weight of evidence based on closely related chemicals

Duration of treatment / exposure:

Weight of evidence based on closely related chemicals

Observation period (in vivo):

Weight of evidence based on closely related chemicals

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

Weight of evidence based on closely related chemicals

Details on study design:

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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Weight of evidence based on closely related chemicals

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Signs of irritation observed

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to eyes. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7
Hence, the possibility of ferric hypophosphite to cause irritation to eyes is quite likely.
Applying the weight of evidence approach, Ferric hypophosphite can considered to be an eye irritant and classified under the category "Category 2" as per CLP.

Executive summary:

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

 

The ocular irritation potential of the test chemical was assessed in rabbits. The study was performed according to OECD 405 and EC Commission Directive 92/69/EEC, Method B5, Acute Toxicity – Eye irritation Guidelines.3.2 mg equivalent to a volume of 0.1 mL of undiluted test chemical was instilled into the eyes of 3 male New Zealand White rabbits.After instillation of the test substance, ocular assessments and clinical observations were performed in the treated eyes for up to 72 hours. Mortality and clinical condition was checked twice daily and rabbits were checked at least once daily for signs of systemic toxicity. Body weights were recorded on the day prior to instillation of test chemical. The treated eyes were assessed at 1, 24, 48 and 72 hours post-instillation and reactions were graded using the standard Draize scale for ocular reactions

 

The reactions elicited included iridial and conjunctival changes, generally very slight but including slight chemosis in one rabbit. No corneal opacity was evident and all of the ocular changes had overtly resolved within 48 -72 hours of dosing. The mean scores for the group of three rabbits over the 24 - 72 hour assessments were 0,0,0,0.44,0 for corneal opacity, iridial response, conjunctival redness, and conjunctival chemosis respectively.

Based on the scores and reversible reactions, the test chemical can be considered to be not irritating to rabbit eyes.

This is supported by An acute eye irritation study performed on New Zealand White rabbit to assess the irritancy potential of the other closely related test chemical.

The test chemical was instilled into the eyes of rabbits and observed for effects.

The gross median score was determined to be 39.0. A conjunctival redness score of 3 was recorded at 4 hours; also noted was haemorrhage of nictitating membrane, upper and lower conjunctive membrane and blood stained discharge and as such the animal was euthanized after the one hour. Hence, on the basis of scores and observations, the test material was determined to be corrosive.

In another eye irritation study for the another closely related chemical, 0.05 - 0.1 cc of 10% solution was injected into the vitreous humor of the rabbit eyes and observed for signs of irritation till 4 weeks. Injection of the test chemical caused a loss of pupillary response to light, marked drop in resting potential of eye measured at cornea and subnormal intraocular pressure in 1- 4 weeks of observation.

Hence, the test chemical can be considered to be severely irritating to eyes.

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to eyes. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to eyes is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be an eye irritant and classified under the category "Category 2" as per CLP.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

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

 

A study was performed to assess the extent of irritation or corrosion caused by test chemical to rabbit skin. The study was performed according to OECD 404 and EC Commission Directive 92/69/EEC, Method B4, Acute Toxicity – Skin irritation.0.5 g of test chemical was applied undiluted to the clipped dorsum skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours. Milli-U water used to moisten the substance to ensure good skin contact. Dermal observations were made for up to 72 hours.

No irritation was observed at any of the treated dermal sites on three rabbits exposed for 4 hours to test chemical. There was no evidence of a corrosive reaction and no indications of dermal staining by the test substance. No mortalities occurred and there were no signs of systemic toxicity recorded.Based on these observations the test chemical can be considered to be not irritating to rabbit skin.

This is supported by a study conducted to determine the extent of irritation or corrosion caused by another closely related test chemical to rabbit skin. The test chemical was applied to back skin of rabbits for one, five, 15 minutes or 20 hours and observed for effects. Exposure to the back skin for 20 hours resulted in slight necrosis, desquamation and scabbing. Hence the test chemical was regarded to be corrosive to rabbit skin.

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to skin. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to skin is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be a skin irritant and classified under the category "Category 2" as per CLP.

Eye Irritation:

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

 

The ocular irritation potential of the test chemical was assessed in rabbits. The study was performed according to OECD 405 and EC Commission Directive 92/69/EEC, Method B5, Acute Toxicity – Eye irritation Guidelines.3.2 mg equivalent to a volume of 0.1 mL of undiluted test chemical was instilled into the eyes of 3 male New Zealand White rabbits.After instillation of the test substance, ocular assessments and clinical observations were performed in the treated eyes for up to 72 hours. Mortality and clinical condition was checked twice daily and rabbits were checked at least once daily for signs of systemic toxicity. Body weights were recorded on the day prior to instillation of test chemical. The treated eyes were assessed at 1, 24, 48 and 72 hours post-instillation and reactions were graded using the standard Draize scale for ocular reactions

 

The reactions elicited included iridial and conjunctival changes, generally very slight but including slight chemosis in one rabbit. No corneal opacity was evident and all of the ocular changes had overtly resolved within 48 -72 hours of dosing. The mean scores for the group of three rabbits over the 24 - 72 hour assessments were 0,0,0,0.44,0 for corneal opacity, iridial response, conjunctival redness, and conjunctival chemosis respectively.

Based on the scores and reversible reactions, the test chemical can be considered to be not irritating to rabbit eyes.

This is supported by An acute eye irritation study performed on New Zealand White rabbit to assess the irritancy potential of the other closely related test chemical.

The test chemical was instilled into the eyes of rabbits and observed for effects.

The gross median score was determined to be 39.0. A conjunctival redness score of 3 was recorded at 4 hours; also noted was haemorrhage of nictitating membrane, upper and lower conjunctive membrane and blood stained discharge and as such the animal was euthanized after the one hour. Hence, on the basis of scores and observations, the test material was determined to be corrosive.

In another eye irritation study for the another closely related chemical, 0.05 - 0.1 cc of 10% solution was injected into the vitreous humor of the rabbit eyes and observed for signs of irritation till 4 weeks. Injection of the test chemical caused a loss of pupillary response to light, marked drop in resting potential of eye measured at cornea and subnormal intraocular pressure in 1- 4 weeks of observation.

Hence, the test chemical can be considered to be severely irritating to eyes.

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to eyes. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to eyes is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be an eye irritant and classified under the category "Category 2" as per CLP.

Justification for classification or non-classification

Even though one of the closely related substance, suggests that Ferric hypophosphite can be not irritating to skin and eyes. But pH of ferric hypophosphite was determined to be in the range of 3.5-3.7

Hence, the possibility of ferric hypophosphite to cause irritation to skin and eyes is quite likely.

Applying the weight of evidence approach, Ferric hypophosphite can considered to be irritant to skin and eyes.

It can be classified under the category "Category 2" as per CLP.