Registration Dossier
Registration Dossier
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EC number: 273-468-9 | CAS number: 68971-49-3
Endpoint summary
Administrative data
Description of key information
Short-term
Fish: LC50 (96 h) > 100 mg/l
Aquatic invertebrates: EC50 48h > 100 mg/l
Algae: ErC50 (72hrs) > 110 mg/l (nominal); NOEC (72hrs, growth rate) = 110 mg/l (nominal)
Long-term
Fish: NOEC (fry length, fry weight) = 4.41 mg/l (time-weighted arithmetic mean measured)
Aquatic invertebrates: NOEC (21d, overall threshold effects) = 1.10 mg/l (nominal)
Additional information
The short-term aquatic toxicity of the substance was evaluated based on data on the substance itself and on data on the similar substance OB 1 -DSA, OB 2 -DSA and OB 3a-MSA. Justification for Read Across is given in Section 13 of IUCLID. At least one reliable study for each of the three acute trophic levels has been reported with EC50 higher than 100 mg/l and showing no general toxicity at high concentrations.
The toxicity of the substance 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 for 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, in a limt test at 110 mg test item/l. The concentrations of the test item were analytically verified at the start (0 hours) and at the end of the exposure (72 hours) in the limit concentration level and in the control. The measured concentrations in the test solutions at the start of the exposure were in the range of 101 to 109% of the nominal concentrations.
Six replicates were tested for each test item concentration and six replicates for the control. The environmental conditions were within the acceptable limits. ErC50 (72hrs) > 110 mg/l (nominal); NOEC (72hrs, growth rate) = 110 mg/l (nominal)
Regarding long term studies, a Daphnia magna reproductive study is available on the similar substance OB 1 -MSA and on the substance OB 3a-DSA.
Justification for Read Across is given in Section 13 of IUCLID.
A reproduction test on Daphnia magna (semi-static, 21 days) was carried out to assess the effect of OB 3a-DSA on the reproductive output of Daphnia magna, according to the OECD Guideline 211. Ten daphnids, held individually, were used per concentration level and control. The daphnids were exposed to the following test concentrations: 1.0 -2.0 -4.0 - 8.0 - 16.0 mg/l. 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 reproduction test on Daphnia magna (semi-static, 21 days) was carried out to assess the effect of the similar substance 1 -MSA on the reproductive output of Daphnia magna, according to the OECD Guideline 211. Ten daphnids, held individually, were used per concentration level and control. Nominal concentrations of the test item were selected based on the results of a preliminary range finding test (non-GLP) as follows: 0.478 - 1.10 - 2.53 - 5.82 - 13.4 mg/l. 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.
The effects of OB 1 -MSA on the early-life stage of fish (Danio rerio/Zebrafish) were determined at the test facility according to OECD Guideline 210. Based on the results of a range finding test the test was conducted as a dose-response test with the nominal test item concentrations 0.301, 0.723, 1.74, 4.17 and 10.0 mg/l. The test was started by placing fertilized eggs into the test vessels and it lasted 34 days (30 days post-hatch). 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 OB 1 -MSA.
The study conducted on the analogue substance OB 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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