4,4'-Isopropylidenediphenol, propoxylated

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to fish, other

Type of information:

other: Assessment of the relevance of long-term toxicity testing on fish

Adequacy of study:

key study

Study period:

2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Assessment of the relevance of long-term toxicity testing on fish

Qualifier:

no guideline required

Principles of method if other than guideline:

Assessment of the relevance of long-term toxicity testing on fish

GLP compliance:

no

Remarks on result:

other: Assessment of the relevance of long-term toxicity testing on fish

Validity criteria fulfilled:

not applicable

Conclusions:

An assessment was performed on the relevance of performing long-term toxicity testing on fish for the registered substance. As a result of this assessment and in accordance with Annex IX of REACH, it is concluded that no long-term toxicity testing on fish is required.

Executive summary:

In accordance with Annex IX, Column 2, of REACH, long-term toxicity testing shall be proposed by the registrant if the CSA conducted in accordance to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the CSA.

An assessment of the environmental exposure to BPA PO and its hazardous properties was conducted as part of the CSA performed in accordance with Annex I of REACH. As part of this assessment seven exposure scenarios were considered.

The Risk Characterisation Ratios (RCRs) were calculated using the PNEC derived from the results of short-term toxicity testing performed on freshwater species. These results were obtained applying the most conservative assessment factor (1,000 for freshwater species and 10,000 for marine species) because of the lack of long-term studies.  Despite the use of the greatest assessment factor available the RCRs are below 1.

The substance carries a classification of Aquatic Chronic 2; H411 based on the EC50 of aquatic invertebrates (48h EC50 = 2.3 mg/L) and the lack of ready biodegradability in accordance with Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. However, this classification takes into account the inherent properties of the substance as such, whereas a RCR takes also into account public and environmental exposure to the chemical, in part determined by usage. Therefore, a risk based approach is considered more appropriate to determine if the hazardous properties of the substance to the aquatic environment will require further testing (UK Royal Society of Chemistry (2007), Hansson et al. (2011) and Lofstedt (2013)). Based on the calculated RCRs BPA PO is not expected to pose a significant risk to the aquatic environment and therefore no further long-term toxicity testing to aquatic species is required.

The CSA shows no concern related to the long-term toxicity of BPA PO to the aquatic environment that can justify additional testing to be performed on aquatic species.

It can therefore be concluded that the CSA does not indicate the need to investigate further the effects on fish.

Description of key information

An assessment of the environmental exposure to BPA PO and its hazardous properties was conducted as part of the CSA performed in accordance with Annex I of REACH. Seven exposure scenarios were considered.

 

The Risk Characterisation Ratios (RCRs) were calculated for all exposure scenarios using the PNEC derived from the results of short-term toxicity testing performed on freshwater species and are below 1. A risk based approach is considered appropriate to determine if the hazardous properties of the substance to the aquatic environment will require further testing. Based on the calculated RCRs BPA PO is not expected to pose a significant risk to the aquatic environment and therefore no further long-term toxicity testing to aquatic species is required.

 

The CSA shows no concern related to the long-term toxicity of BPA PO to the aquatic environment that can justify additional testing to be performed on aquatic species.

 

It can therefore be concluded that the CSA does not indicate the need to investigate further the effects on fish.