Bis(5-oxo-L-prolinato-N1,O2)zinc

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Based on the modelled conditions, the reproductive NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

Link to relevant study records

Reference

Reference 1

Endpoint:

reproductive toxicity, other

Remarks:

Not specified

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source

Justification for type of information:

A read-across justification report (RAAF) will be added to Section 13 as soon as possible.

Qualifier:

according to guideline

Guideline:

other: REACH guidance on QSARs R.6. May/July 2006

Deviations:

not specified

Principles of method if other than guideline:

This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

The outcome of the QSAR model is “Known precedent reproductive and developmental toxic potential”, if the chemical has a potential to cause toxicity. The corresponding category is displayed in the report generated for the obtained prediction.

The other prediction results are “Not known precedent reproductive and developmental toxic potential” if the toxic potential of the input chemical is not known, and “Not covered by current version of the decision tree” if the identified structural features are not objects of the tree.

GLP compliance:

no

Remarks:

As no laboratory work took place, compliance with GLP is not required.

Species:

other: QSAR; species not specified

Dose descriptor:

other: Developmental toxicity potential

Based on:

not specified

Sex:

not specified

Basis for effect level:

other: Not known precedent reproductive and developmental toxic potential.

Remarks on result:

not measured/tested

Critical effects observed:

not specified

Dose descriptor:

other: Reproductive toxicity potential

Generation:

other: Not specified

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Not known reproductive and developmental toxic potential

Remarks on result:

not measured/tested

Critical effects observed:

not specified

Reproductive effects observed:

not specified

Toxicity of the target chemical (Not known precedent reproductive and developmental toxic potential) is predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The current prediction has no applicability domain.

Conclusions:

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Executive summary:

The potential of the test material to cause reproductive or developmental toxicity was modelled using the OECD QSAR Toolbox. This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

 

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Reference 2

Endpoint:

reproductive toxicity, other

Remarks:

Not specified

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The following prediction was performed using the OECD QSAR Toolbox. A category was formed based on the current endpoint (DART scheme). The prediction was further refined from a large database of metadata based on relevant subcategories.

Justification for type of information:

A read-across justification report (RAAF) will be added to Section 13 as soon as possible.

Qualifier:

according to guideline

Guideline:

other: REACH Guidance on QSARs R.6, May/July 2008

GLP compliance:

no

Remarks:

As no laboratory work took place, compliance with GLP is not required.

Species:

rabbit

Strain:

not specified

Dose descriptor:

NOEL

Effect level:

368 mg/kg bw/day

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Based on the modelled conditions

Remarks on result:

not measured/tested

Remarks:

The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Critical effects observed:

not specified

Dose descriptor:

NOEL

Generation:

other: Not specified

Effect level:

368 mg/kg bw/day

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Based on the modelled conditions

Remarks on result:

not measured/tested

Remarks:

The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Critical effects observed:

not specified

Reproductive effects observed:

not specified

Lowest effective dose / conc.:

368 mg/kg bw/day

Treatment related:

not specified

The prediction was based on dataset comprised from the following descriptors: NOEL

Estimation method: Takes average value from the 5 nearest neighbours

Domain logical expression: Result: In Domain

 

Substances used for the prediction should be:

Not known precedent reproductive and developmental toxic potential 'Strict' (DART scheme)

<AND> Bioavailable (Lipinski Rule Oasis)

Conclusions:

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

Executive summary:

The developmental toxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the DART scheme category, and the results were refined using relevant subcategories.

 

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

 

The target chemical falls within the applicability domain of the prediction.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

The potential of the test material to cause reproductive or developmental toxicity was modelled using the OECD QSAR Toolbox. This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

The reproductive toxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the DART scheme category, and the results were refined using relevant subcategories.

Based on the modelled conditions, the reproductive NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

The target chemical falls within the applicability domain of the prediction.

Effects on developmental toxicity

Description of key information

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

Link to relevant study records

Reference

Reference 1

Endpoint:

developmental toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a (Q)SAR model, with limited documentation / justification, but validity of model and reliability of prediction considered adequate based on a generally acknowledged source

Justification for type of information:

See read-across justification in Section 13.

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

REACH Guidance on QSARs R.6, May/July 2008

Principles of method if other than guideline:

This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

The outcome of the QSAR model is “Known precedent reproductive and developmental toxic potential”, if the chemical has a potential to cause toxicity. The corresponding category is displayed in the report generated for the obtained prediction.

The other prediction results are “Not known precedent reproductive and developmental toxic potential” if the toxic potential of the input chemical is not known, and “Not covered by current version of the decision tree” if the identified structural features are not objects of the tree.

GLP compliance:

no

Remarks:

As no laboratory work took place, compliance with GLP is not required.

Limit test:

no

Species:

other: QSAR; species not specified

Dose descriptor:

other: Developmental toxicity potential

Based on:

not specified

Basis for effect level:

other: Not known precedent reproductive and developmental toxic potential.

Remarks on result:

not measured/tested

Dose descriptor:

other:

Based on:

not specified

Sex:

not specified

Basis for effect level:

other: Not known precedent reproductive and developmental toxic potential

Remarks on result:

not measured/tested

Abnormalities:

not specified

Developmental effects observed:

not specified

Toxicity of the target chemical (Not known precedent reproductive and developmental toxic potential) is predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The current prediction has no applicability domain.

Conclusions:

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Executive summary:

The potential of the test material to cause reproductive or developmental toxicity was modelled using the OECD QSAR Toolbox. This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

Reference 2

Endpoint:

developmental toxicity

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The following prediction was performed using the OECD QSAR Toolbox. A category was formed based on the current endpoint (DART scheme). The prediction was further refined from a large database of metadata based on relevant subcategories.

Justification for type of information:

See Read-Across Justification in Section 13.

Qualifier:

according to guideline

Guideline:

other: REACH Guidance on QSARs R.6, May/July 2008

GLP compliance:

no

Remarks:

As no laboratory work took place, compliance with GLP is not required.

Limit test:

no

Species:

rabbit

Strain:

not specified

Dose descriptor:

NOEL

Effect level:

368 mg/kg bw/day

Based on:

test mat.

Basis for effect level:

other: Based on the modelled conditions

Remarks on result:

not measured/tested

Remarks:

The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Abnormalities:

not specified

Dose descriptor:

NOEL

Effect level:

368 mg/kg bw/day

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: Based on the modelled conditions

Remarks on result:

not measured/tested

Remarks:

The prediction was based on the average value from the 5 nearest neighbours compared by prediction descriptors.

Abnormalities:

not specified

Developmental effects observed:

not specified

Lowest effective dose / conc.:

368 mg/kg bw/day

Treatment related:

not specified

The prediction was based on dataset comprised from the following descriptors: NOEL

Estimation method: Takes average value from the 5 nearest neighbours

Domain logical expression:Result: In Domain

Substances used for the prediction should be:

Not known precedent reproductive and developmental toxic potential 'Strict' (DART scheme)

<AND> Bioavailable (Lipinski Rule Oasis)

Conclusions:

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

Executive summary:

The developmental toxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the DART scheme category, and the results were refined using relevant subcategories.

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

The target chemical falls within the applicability domain of the prediction.

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Effect on developmental toxicity: via inhalation route

Endpoint conclusion:

no study available

Effect on developmental toxicity: via dermal route

Endpoint conclusion:

no study available

Additional information

The potential of the test material to cause reproductive or developmental toxicity was modelled using the OECD QSAR Toolbox. This QSAR model is based on profiling results obtained by DART scheme v 1.0. This QSAR is used for identifying chemicals with structural features associated with the potential to act as reproductive or developmental toxicants.

Toxicity of the target chemical was predicted by QSAR "Developmental and Reproductive Toxicity (DART)". The target chemical was predicted to fall under the category "Not known precedent reproductive and developmental toxic potential".

The developmental toxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the DART scheme category, and the results were refined using relevant subcategories.

Based on the modelled conditions, the developmental NOEL of the test material in the rabbit was determined to be ca. 370 mg/kg bw/day.

The target chemical falls within the applicability domain of the prediction.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008 (CLP), the substance does not require classification with respect to reproductive or developmental toxicity.