Registration Dossier
Registration Dossier
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EC number: 255-217-5 | CAS number: 41098-56-0
Endpoint summary
Administrative data
Description of key information
Short-term toxicity
Fish: LC50 (96 h) > 100 mg/l
Aquatic invertebrates: EC50 (48h)> 100 mg/l
Algae: ErC50 (72h) > 120 mg/l (nominal); NOEC (growth rate, 72h) = 120 mg/l (nominal)
Long-term toxicity
Fish: NOEC (fry length, fry weight) = 4.41 mg/l (TWA, mean measured)
Aquatic invertebrates: NOEC (21d, overall threshold effects) = 1.10 mg/l (nominal)
Additional information
The short-term toxicity to fish and to aquatic invertebrates were assessed based on data on the substance itself. The EC50 was reported as higher than 100 mg/l, showing no general toxicity at high doses.
The toxicity to aquatic algae was assessed considering data also on the similar substance 1 -MSA, 2 -DSA, 3a-DSA.
Justification for Read Across is given in Section 13 of IUCLID.
The toxicity of the test item to the unicellular freshwater green alga Pseudokirchneriella subcapitata was determined according to the principles of OECD 201 and Council Regulation (EC) No. 266/2016/Method C.3. The aim of the study was the determination of the effects on growth rate and yield over a period of 72 hours. The study was conducted under static conditions with an initial cell density of 5416 cells/ml. Five concentrations were tested in a geometrical series. Three replicates were tested for each test item concentration and six replicates for the control. The following results were obtained:
1 -MSA: ErC50 (72h) > 120 mg/l (nominal); NOEC (growth rate, 72h) = 120 mg/l (nominal).
2 -DSA: ErC50 (72h) > 126 mg/l (nominal); NOEC (growth rate, 72h) = 126 mg/l (nominal).
3a-DSA: ErC50 (72h) > 110 mg/l (nominal); NOEC (growth rate, 72h) = 110 mg/l (nominal).
Regarding long term studies, a Daphnia magna reproductive study is available on the similar substance 1 -MSA and 3a-DSA, conducted according to the OECD Guideline 211 and under GLP conditions.The effects on reproduction were evaluated based on the reproduction per introduced parent animal. The overall effect threshold for effects of the test item under the test conditions was 1.10 mg/l (NOEC) and 2.53 mg/l (LOEC) based on the nominal concentrations. Justification for Read Across is given in Section 13 of IUCLID.
The following results were obtained:
1 -MSA: The overall effect threshold for effects of the test item under the test conditions was 1.10 mg/l (NOEC) and 2.53 mg/l (LOEC) based on the nominal concentrations.
3a-DSA: The overall effect threshold for effects of the test item on daphnid reproduction under the test conditions was 2.0 mg/l (NOEC) and 4.0 mg/l (LOEC) based on the nominal concentrations of the test item.
A long-term toxicity to fish study is also available for the similar substance 1 -MSA. The effects of the test item on the early-life stage of fish (Danio rerio/Zebrafish) were determined according to OECD Guideline 210 For both studies. The test was started by placing fertilized eggs into the test vessels and it lasted for 34 days (30 days post-hatch). 80 eggs of Danio rerio / zebrafish were exposed to each test concentration, the solvent control and the control (4 replicates with 20 eggs each). The water quality parameters pH-value, oxygen concentration, temperature and total hardness were within the acceptable limits. Hatching success, fry growth (assessed via length and fresh weight measurements on PHD 30), morphological and behavioral effects, posthatch survival and overall survival were assessed. The test item partly caused significant effects on Zebrafish in an early life stage test. For the parameters hatch, post-hatch survival and overall survival the NOEC was 10.8 mg/L. Therefore, the respective LOECs were determined to be > 10.8 mg/l. For the parameter fry growth (expressed as length and fresh weight) the NOEC was 4.41 mg/l. Therefore, the LOEC for this parameter was determined to be 10.8 mg/l.
Considering the available data on the three trophic levels, daphnia is considered to be the most sensitive species as the effect level during the long-term reproductive study was the lowest obtained.
Therefore, SELECTED NOEC for aquatic toxicity: 1.10 mg/l from the 21-days reproductive Daphnia study on the analogue substance 1 -MSA.
The study conducted on the analogue substance 1 -MSA is used for the chemical safety assessment, following a conservative approach. More information on the results of the substances of the category are found on the document attached under "Ecotoxicological information".
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