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Ecotoxicological information

Long-term toxicity to fish

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Description of key information

The available data show that, under reasonable, normal environmental conditions, Al will not cause a concern for chronic toxicity at concentrations below 74.4 μg/L. The ERGTC have generated data to show that the substance has a low water solubility of ≤ 12.5 µg/L at 20°C based on total Al concentration and, therefore, is unlikely to occur in water at concentrations high enough to cause a toxicity concern.

Key value for chemical safety assessment

Additional information

In accordance with column 2 of REACH Annex IX, the long-term testing on aquatic organisms does not need to be conducted as the chemical safety assessment according to Annex I has not indicated a need to investigate further the effect on aquatic organisms.

Based on read across from aluminum, benzoate C16-18-fatty acids complexes, the substance is not considered to be acutely toxic to fish, invertebrates or inhibitory to algal growth as the substance is expected to have acute LL or EL50s of >100 mg/L (WAF). The acute toxicity of aluminum, benzoate C16-18-fatty acids complexes to rainbow trout (Oncorhynchus mykiss) and Daphnia magna and toxicity to algal growth showed no effects at a water accommodated fraction nominal loading rate of 100 mg/L. Therefore, for fish the 96 hour LL50 is > 100 mg/L (WAF), for Daphnia the 48 hour EL50 is >100 mg/L (WAF) and for algal growth inhibition the 72 hour EL50 is >100 mg/L (WAF). No data are available for the long-term toxicity to invertebrates or fish for the substance but the toxicity of aluminum, benzoate C16-18-fatty acids complexes to algal growth showed no effects at a water accommodated fraction loading rate of 100 mg/L. Therefore, the 72 hour NOErLR is 100 mg/L (WAF) (Harlan 2013).

REACH Chapter R5 (ECHA 2011) states that chronic aquatic ecotoxicity testing may be triggered if the CSA indicates that there is a need to investigate further the effects on the environment. Testing may be triggered if additional testing could alter the conclusions on classification, PBT assessment or the level of concern. The substance in isolated form (i.e. extracted from base oil) is considered readily biodegradable but the substance at 50% w.w. concentration in pharmaceutical white oil (i.e. as representative of the form in which it is marketed and used) is considered not readily biodegradable and this conclusion has been used in the hazard assessment. The substance has a low potential for bioaccumulation and is expected to show no acute toxicity at up to 100 mg/L (WAF). No chronic effects are expected in the algal toxicity tests at 100 mg/L (WAF). Additional chronic toxicity tests would therefore not lead to changes in the classification or the conclusion that this substance is neither PBT nor vPvB. As the substance is not classified or considered to be PBT/vPvB, an exposure assessment is not required and so additional chronic testing is not required to refine this assessment (ECHA R7b 2012).

No data are available for the long-term ecotoxicity of the substance, though some read across data are available.The organic moieties of the substance, and the structural analogue Aluminum, benzoate C16-18-fatty acids complexes, are namely stearic acid, palmitic acid, benzoic acid and isopropyl alcohol (2-propanol). The organic moieties are known to have low toxicity to aquatic organisms and are not classified for hazardous effects on the environment. Therefore, it is assumed that any potential for long-term ecotoxicity would be due to the Aluminium (Al) component of the substances.

Long term ecotoxicity data for Al are presented in IUCLID for algae (Raphidocelis subcapitata formally Pseudokirchneriella subcapitata), invertebrates (Ceriodaphnia dubia and Daphnia magna) and fish (Pimephales promelas). The toxicity of Al to aquatic organisms varies due to changes in environmental parameters such as pH, hardness and dissolved organic carbon (DOC). The data reported in IUCLID covers effects on standard test organisms taking into consideration changes in the relevant environmental parameters. The data covers a circumneutral pH range of 6-8 which would cover most natural surface waters in Europe. The data have been reported based on total Al concentration because the aquatic toxicity results should cover both the dissolved phase and also the presence of Al solids which can cause adverse physical effects (Gensemer et al. 2017).

The available data show that, under reasonable, normal environmental conditions, Al will not cause a concern for chronic toxicity at concentrations below 74.4 μg/L. The ERGTC have generated data to show that the substance has a low water solubility of ≤ 12.5 µg/L at 20°C based on total Al concentration and, therefore, is unlikely to occur in water at concentrations high enough to cause a toxicity concern.

Furthermore, the substance is not used in isolated form but as a grease thickener within base oil. The ERGTC have conducted leaching studies on the substance in deionised water which show that, when present within a grease base, the grease thickener is not bioaccessible. The leaching studies were conducted using Water Accommodated Fractions (WAFs) at a loading rate of base grease (thickener in a base oil to form a grease matrix) of 1000 mg/L, with the substance being present at 50% in medicinal white oil. In the leaching studies, no Al was detected in water at the analytical method (ICP-MS) limit of detection (LOD) of 5 µg/L. On the basis of the information presented, the substance would not be expected to cause a concern for chronic toxicity to aquatic organisms. Therefore, experimental testing to satisfy REACH data requirements for these endpoints are waived.

This substance has been registered by a Member of the European REACH Grease Thickeners Consortium (ERGTC). A number of decisions have been made in the dossier with regard to the approach taken for registering the substance including the testing strategy and the justification for waiving certain endpoints. Several of the decisions reflect the technical difficulties of testing the substance and the relevance of data with regard to the potential for exposure, given that the substance typically occurs in situ in base oil. A face to face meeting between the ERGTC and ECHA was held in Helsinki on 8th September 2016 which discussed many of these topics and a copy of the minutes from the meeting are attached to the dossier (See section 13 of IUCLID). Therefore, if there are any queries or concerns which arise when the dossier is reviewed, it is requested that the reviewer discuss these with the ERGTC (ERGTC@wca-consulting.com) as there may be background information and previously discussions between the ERGTC and ECHA available which are relevant.