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Long-term toxicity to fish

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Reference
Endpoint:
fish life cycle toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
The performance of a test for long-term toxicity to fish was considered not scientifically justified. REACH Regulation No. 1907/2006, Annex IX, Sect. 9.1., Col. 2, states as follows: “9.1.: Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.”

The chemical safety assessment does not indicate the need to further investigate the effects on aquatic organisms for the following reasons:

Exposure and stability considerations:
The test item is not stable in the aquatic environment. Due to the unstable nature of organic peroxides, it can be assumed that upon contact with water and organic matter, the test item undergoes degradation resulting in the formation of respective alcohols and acids. Therefore, an abiotic degradation of the test item in the environment is expected. In addition, the test item was found to be readily biodegradable in a closed bottle test.
The test item itself is highly insoluble in water. Solubility was estimated to be << 1 µg/L. It is further not expected to have potential for bioaccumulation (calculated BCF = 15.1 L/kg).
Consequently, long-term toxicity testing is considered scientifically not justified since the test item is not stable in the aquatic environment and long-term exposure to aquatic animals is considered to not occur.

Further, Environmental Risk Assessment revealed safe use of the substance throughout its whole life cycle due to very low exposure of the water compartment which is especially based on the following facts:

Organic peroxides, when released into the sewage of a plant production or a downstream user’s plant, are treated with other substances in dedicated sewage treatment plants. The activated sludge stemmed from these sewage treatment plants are then extracted and treated as chemical waste. From the production plant, the release of organic peroxide into the sewage is very limited, not to say completely negligible. The waste water from production plant can be treated on site (at least a physical/chemical treatment, which will neutralize potential residual organic peroxide), which is usually followed by a biological treatment. Regarding the rest of the lifecycle, organic peroxides are mainly used as cross-linking agent/polymerization initiator for the production of resins/rubbers/polymers. Based upon the fact that organic peroxides are totally consumed during the process (>99%, which is confirmed by the release factor to sewage for curing agents from ESD n°3), the surface water is not exposed to organic peroxides via the waste water system. As a consequence, the surface water and with this aquatic organisms are not considered to be significantly exposed by the test item.

Thus, the CSA does not show a need for an additional long-term aquatic test. Risk assessment is based on the long-term daphnia study.

In summary, long-term toxicity testing in a vertebrate species is considered not scientifically justified according to REACH Regulation No. 1907/2006, Annex IX, Sect. 9.1., Col. 2 and not in line with animal welfare.

Description of key information

The performance of a test for long-term toxicity to fish was considered not scientifically justified. REACH Regulation (EC) No 1907/2006, Annex IX, Sect. 9.1., Col. 2, states as follows:

"9.1.: Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.” 

The chemical safety assessment does not indicate the need to further investigate the toxicity to aquatic organisms.

The test substance ditetradecyl peroxydicarbonate is highly insoluble in water. The water solubility was estimated to be << 1 µg/L. Therefore, aquatic toxicity is unlikely to occur. Thus, the CSR does not show a need for an additional long-term aquatic test. Risk assessment is based on the long-term daphnia study.

Key value for chemical safety assessment

Additional information