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EC number: 614-345-5
CAS number: 68155-40-8
Fish are in general less sensitive to the primary fatty amine ethoxylates compared to algae and daphnia. The available acute fish data for the primary fatty amine ethoxylates category which covers an alkyl chain length range from C12 to C18 reveals only a slight increase of the toxicity in relation to an increasing alkyl chain length.
As long-term NOECs from species representing two trophic levels are available (algae and daphnia) an assessment factor of 50 may be used. Based on the observed comparable or lower toxicity to fish for primary fatty amine ethoxylates it is considered unlikely that fish toxicity will be critical for primary fatty amine ethoxylates. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of the primary fatty amine ethoxylates other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare. This means that it is proposed to waive the long term fish unless a further refinement of the effect assessment is considered necessary based on the outcome of the chemical safety assessment.
For primary fatty amine ethoxylates a safety factor of 50 is applied.
Most of the short-term toxicity fish tests were conducted in a period
when no reliable specific method of analyses was available. The
concentrations were therefore not analytically verified, the reliability
of the results is limited because of the poor solubility of the test
substances and partial sorption onto the walls of test vessels. Hence,
most of the tests were considered to be valid with restrictions. The
available data reveal a comparable toxicity independent of the chain
length. A recent GLP study by CECA (2009) is considered more reliable
than the other endpoints, although it was conducted in standard test
medium, with LC50 of 0.1 mg/L is used for risk assessment purposes.
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