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EC number: 200-609-3 | CAS number: 65-45-2
Table 1. Effect on the Mobility of Daphnia magna
The sensitivity of Daphnia magna to the test material was determined in a GLP-compliant test performed to standard guidelines. The 48-hour EC50 was found to be 37 mg/L with 95 % confidence intervals of 30 - 45 mg/L. The 48-hour NOEC was determined to be 22 mg/L. All results are based on nominal concentrations.
Immobilisation of Daphnia magna at 24 and 48h.
No. Immobile 24h
No. Immobile 48h
pH range in starting flasks: 7.1 to 7.3; Oxygen concentration range in starting flasks: 5.8 to 6.0.
pH range in flasks at end: 7.7 to 7.8; Oxygen concentration range in flasks at end: 6.1 to 6.4.
Replicates were combined to give average pH and oxygen concentrations at the end of the test.
The acute toxicity of salicylamide to daphnia magna was investigated under static exposure conditions over a period of 48h. A screening test with nominal concentrations of 100, 10, and 1mg/L was performed. 40 individual daphnia divided in 2 test vessels were exposed to each conetration of the test substance. No analytical verification of the test material was conducted; evaluation of the test was based on nominal concentrations assuming the substance to be stable in water over a 48h period. Based on the immobilisation data, the nominal EC50(48h) of salicylamide to daphnia magna was estimated to be 10 -100mg/L. The NOEC was 10mg/L after 48h exposure. Almost 100% immobilisation was observed at the nominal concentration of 100mg/L after 48h.
EC50 = 37 mg/L, 48h, Daphnia magna, OECD 202, Höger 2010EC50 = 10 - 100 mg/L, 48h, Daphnia magna, screening test, Häner 2007
The acute toxicity of the substance to Daphnia magna was determined in a 48-hour static screening test, by Häner (2007). The study was conducted under a recognised quality control standard. No analytical measurements were performed. The 48h EC50 was found to be in the range 10-100 mg/L, with a NOEC of 10 mg/L over the same period. Almost 100% immobilisation was seen at the nominal 100 mg/L concentration.
The acute toxicity of the substance to Daphnia magna was determined in a 48-hour static test under GLP and according to OECD Guideline 202 (2004), by Höger (2010). The nominal concentrations tested were control group, 4.6, 10, 22, 46 and 100 mg/L. No analytical measurements were performed in the test. The 48h EC50 was found to be 37 mg/L (30-45 mg/L, CI=95%) based on nominal concentrations.The pH was reported in the range 7.5-7.8.
The EC50 result of the guideline study falls within the range determined by the screening level study. The two available studies both have shortcomings in the experimental design, but the independent determinations lend credibility to the results. However, this consistency does not remove any inherent uncertainty due to potential hydrolysis.
In literature studies investigating hydrolysis, the substance has been shown to be hydrolytically unstable, but under strongly acid and alkaline conditions at elevated temperatures (~100 °C). No experimental information is available at relevant temperatures - see section 5.1.2. However, the algae growth inhibition study by Liedtke (2010) demonstrated a decrease in salicylamide concentration during the 96 h study period, which may be attributable to hydrolysis (the pH observed at the end of the study was 8.2-9.4).
As a result, the aquatic invertebrate study by Höger is not considered in itself to be fully reliable, as toxicity may be underestimated due to the lack of analytical measurements of test item concentrations during the study. However, the neutral pH of the test media, and half the duration (48h) of the algae study, are likely to mitigate the degree of test concentration reduction which was observed by Liedtke. Finally, the Daphnia magna EC50 (37 mg/L) is significantly higher than regulatory cut-offs for classification (at 10 mg/L), and is not used for risk assessment (PNEC derivation), both of which are driven by the toxicity to algae.
The available data is thus considered to be adequate for the purposes of classification and labelling and risk assessment based on the weight-of-evidence, in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.2.
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