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EC number: 250-705-4
CAS number: 31566-31-1
The chemical safety assessment carried out according to Annex I of Regulation (EC) No 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.
According to Regulation (EC) No. 1907/2006, Annex IX, Column 2,
9.1.6, 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. Stearic acid,
monoester with glycerol (CAS No. 31566 -31 -1) is a readily
biodegradable and poorly soluble substance (< 1 mg/L). Due to these
characteristics, extensive biodegradation and adsorption to activated
sludge within conventional STPs can be expected and therefore, only low
concentrations, if any, are likely to be released into the water phase.
Fish exposure to this substance is thus expected to be low.
Furthermore, the acute test conducted with fish (on a suitable
read-across substance) showed no mortality after 96 hours of exposure,
under semi-static conditions. The reports evaluating the acute and
chronic toxicity to Daphnia magna (read-across) reported no effects up
to the limit of water solubility either (EC50 (48 h) > 100 mg/L and
NOELR (21 d) ≥ 10 mg/L (nominal concentration), for short and long-term
studies, respectively). The study conducted with algae (read-across)
showed low toxicity to Scenedesmus subspicatus (EC50 (72 h) > 100 mg/L,
Based on the short term values, fish cannot be identified as the
most sensitive organism. According to the Guidance on information
requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012),
long-term toxicity testing on fish should only be conducted if it
represents the most sensitive taxonomic group. The Guidance states that
if invertebrates are likely to be more sensitive than fish and algae or
the relative sensitivity of invertebrates cannot be predicted, long-term
testing on Daphnia sp. should be preferred instead of fish. Considering
this information, long-term toxicity testing on fish species is not
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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