Registration Dossier

Skin Irritation:

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

Manganese(2+) bis(phosphinate) was estimated to be not irritating to skin.

Eye Irritation:

On the basis of available studies for the closely related chemicals, the weight of evidence approach was applied to assess the ocular irritation potential for manganese(2+) bis(phosphinate).

Manganese(2+) bis(phosphinate) was estimated to be irritating to eyes.

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 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 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 irritation potential of manganese(2+) bis(phosphinate)

GLP compliance:

not specified

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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

male

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

0.5 ml moistened with water

Duration of treatment / exposure:

4 hours

Observation period:

24, 48 and 72 hours

Number of animals:

3

Details on study design:

The study is based on weight of evidence approach from the read across values

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No signs of irritation observed

Interpretation of results:

other: not irritating

Conclusions:

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

Executive summary:

Based on the available studies for closely related chemicals, weight of evidence approach was applied to assess the dermal irritation potential of manganese(2+) bis(phosphinate).

The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.0.5 g of the test chemical (mixed with 0.5 ml of distilled water to create a paste) was applied to the shaven skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours. The test sites were observed for erythema and edema 24 hours post exposure till 7 days.

One rabbit showed erythema (score = 2) and oedema (score = 1) at 24 hours postexposure, both of which were reversed by seven days post-exposure.

Since the effects were reversible in 7 days, hence the test chemical was considered to be not irritating to skin.

This is supported by the results of similar study conducted according to OECD 404 Guidelines for other closely related chemical.0.5 g of the test chemical (mixed with 0.5 ml of distilled water to create a paste) was applied to the shaven skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours.

The rabbits were observed 24, 48 and 72 hours post exposure.

No signs of irritation were observed after 72 hours of observation.

Hence, the test chemical was considered to be not irritating to skin.

Based on the available data for the closely related chemicals and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar mannerthat of the read across substances. Therefore,Manganese(2+) bis(phosphinate)was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Endpoint conclusion:

no adverse effect observed (not irritating)

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 similar chemicals

Justification for type of information:

Weight of evidence 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 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 ocular irritation of manganese(2+) bis(phosphinate)

GLP compliance:

not specified

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:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

sex: male/ female

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

1. 24,48, 72 hours till 10 days
2. 24,48, 72 hours till 10 days

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

1. 3 female
2. 2 male

Details on study design:

The study is based on weight of evidence approach from the read across values

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

21 d

Reversibility:

not fully reversible within: 21 Days

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:

On the basis of available studies for the closely related chemicals the weight of evidence approach was applied to assess the ocular irritation potential for manganese(2+) bis(phosphinate).
Manganese(2+) bis(phosphinate) was estimated to be irritating to eyes.

Executive summary:

Based on the available studies for closely related chemicals, weight of evidence approach was applied to assess the ocular irritation potential of manganese(2+) bis(phosphinate).

The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines. 100 mg of undiluted test chemical was instilled in the eyes of 3 female New Zealand White rabbits and observed for signs of irritation till 10 days.It was observed that corneal opacity was minimal (average 0.33/4 for all animals over the 24, 48 and 72 hour time-points), but that it was not fully reversed within 72 hours in one rabbit. There was no iritis in any rabbit over the duration of the study. The average score for conjunctival redness was 3/3 for all animals over the 24, 48 and 72 hour time-points, but this was fully reversible within 10 days. The average score for chemosis was 3/4 for all animals over the 24, 48 and 72 hour time-points and chemosis was not fully reversed within seven days in one rabbit.

Since the most of the effects were not reversible by 10 days, the test chemical can be considered to be irritating to eyes.

This is supported by the results of similar study conducted according to OECD 405 Guidelines for other closely related chemical. 100 mg of undiluted test chemical was instilled in the eyes of 2 male New Zealand White rabbits and observed for signs of irritation till 21 days. The maximum mean total score was 53/110 at 48 hours post-exposure, and corneal and conjunctival lesions were not reversible by 21 days post-exposure. Since the most of the effects were not reversible by 21 days, the test chemical can be considered to be severely irritating to eyes.

Based on the available data for the closely related chemicals and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar mannerthat of the read across substances. Therefore,Manganese(2+) bis(phosphinate)was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

Endpoint conclusion:

adverse effect observed (irritating)

Endpoint conclusion:

no study available

Skin Irritation:

Based on the available studies for closely related chemicals, weight of evidence approach was applied to assess the dermal irritation potential of manganese(2+) bis(phosphinate).

The dermal irritation potential of the test chemical was assessed in rabbits according to OECD 404 Guidelines.0.5 g of the test chemical (mixed with 0.5 ml of distilled water to create a paste) was applied to the shaven skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours. The test sites were observed for erythema and edema 24 hours post exposure till 7 days.

One rabbit showed erythema (score = 2) and oedema (score = 1) at 24 hours postexposure, both of which were reversed by seven days post-exposure.

Since the effects were reversible in 7 days, hence the test chemical was considered to be not irritating to skin.

This is supported by the results of similar study conducted according to OECD 404 Guidelines for other closely related chemical. .0.5 g of the test chemical (mixed with 0.5 ml of distilled water to create a paste) was applied to the shaven skin of 3 male New Zealand White rabbits under semi-occlusive conditions for 4 hours.

The rabbits were observed 24, 48 and 72 hours post exposure.

No signs of irritation were observed after 72 hours of observation.

Hence, the test chemical was considered to be not irritating to skin.

Based on the available data for the closely related chemicals and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar mannerthat of the read across substances. Therefore,Manganese(2+) bis(phosphinate)was estimated to be not irritating to skin and it can be further classified under the category “Not Classified” as per CLP regulation.

Eye Irritation:

Based on the available studies for closely related chemicals, weight of evidence approach was applied to assess the ocular irritation potential of manganese(2+) bis(phosphinate).

The ocular irritation potential of the test chemical was assessed in rabbits according to OECD 405 Guidelines. 100 mg of undiluted test chemical was instilled in the eyes of 3 female New Zealand White rabbits and observed for signs of irritation till 10 days.It was observed that corneal opacity was minimal (average 0.33/4 for all animals over the 24, 48 and 72 hour time-points), but that it was not fully reversed within 72 hours in one rabbit. There was no iritis in any rabbit over the duration of the study. The average score for conjunctival redness was 3/3 for all animals over the 24, 48 and 72 hour time-points, but this was fully reversible within 10 days. The average score for chemosis was 3/4 for all animals over the 24, 48 and 72 hour time-points and chemosis was not fully reversed within seven days in one rabbit.

Since the most of the effects were not reversible by 10 days, the test chemical can be considered to be irritating to eyes.

This is supported by the results of similar study conducted according to OECD 405 Guidelines for other closely related chemical. 100 mg of undiluted test chemical was instilled in the eyes of 2 male New Zealand White rabbits and observed for signs of irritation till 21 days. The maximum mean total score was 53/110 at 48 hours post-exposure, and corneal and conjunctival lesions were not reversible by 21 days post-exposure. Since the most of the effects were not reversible by 21 days, the test chemical can be considered to be severely irritating to eyes.

Based on the available data for the closely related chemicals and applying the weight of evidence approach, it can be concluded that the target chemical will also tend to behave in a similar mannerthat of the read across substances. Therefore,Manganese(2+) bis(phosphinate)was estimated to be irritating to eyes and it can be further classified under the category “Category 2” as per CLP regulation.

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

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