Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

In the absence of adequate aquatic chronic toxicity information from all three trophic levels, the classification was based on the available short-term aquatic toxicity values from laboratory experimental studies (72-h ErC50 = 22 mg/L in algae, 48-h LC50 = 28 mg/L in daphnids) from two trophic levels. In the absence of a laboratory study on acute toxicity in fish, the results of a reliable QSAR model were considered. ECOSAR is an ecotoxicity prediction model contained within EPI Suite version 4.11, a reliable QSAR program developed and validated by the United States Environmental Protection Agency; this program is included in the OECD (Q)SAR Toolbox for use in filling REACH data gaps. The ECOSAR v1.11 predictions indicated that the fish is the least sensitive trophic level with respect to acute aquatic toxicity, considering both baseline toxicity (neutral organics) and predicted class toxicity (aliphatic amines). Therefore, environmental classification was based upon the lower of the two L(E)C50 values for algae and aquatic invertebrates (i.e., the 72-h ErC50 of 22 mg/L in algae). The substance has not been shown to be readily biodegradable (the key study reported 5% degradation in 28 days), and has an estimated octanol-water partition coefficient of log Kow = 3.36. Therefore, the substance has been classified as Category Chronic 3.