Registration Dossier
Registration Dossier
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EC number: 267-097-1 | CAS number: 67786-25-8
Endpoint summary
Administrative data
Description of key information
Short-term toxicity
Fish: LC50 (96 h) > 300 mg/l
Aquatic invertebrates: EC50 (48h) > 113 mg/l
Algae: EC50 (72 h) > 100 mg/l
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
Additional information
The short-term toxicity of the substance was evaluated for the three acute trophic levels, by considering data on the substance and on similar substance 3a-MSA. Justification for Read Across is given in Section 13 of IUCLID. The effect levels for all three aquatic organisms were greater from 100 mg/l and no general toxicity at higher doses was observed.
The outcomes on the substance under registration are supported by several consistent studies mainly performed on the analogous substance of the Stilbene Fluorescent Whitening Agents category 3a-MSA. This substance can be considered the best representative within the category, since it has the same sulphonation degree with 4 -MSA, a very high structural similarity (Tanimoto distance > 0.9) and a very high water solubility (650 g/l vs 1000 g/l of 4 -MSA).
Regarding long-term studies, a Daphnia magna reproductive study is available on 4 -MSA and on the similar substance 1 -MSA.
A reproduction test on Daphnia magna (semi-static, 21 days) was carried out to assess the effect of the test item 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: 0.625 - 1.38 - 3.03 - 6.66 - 14.6 mg/l (separation factor 2.2). The effects on reproduction were evaluated based on the reproduction per introduced parent animal, since this parameter is the ecologically most relevant response variable and is required by the OECD test guideline 211 (2012), when a significant trend in mortality is detected. The overall effect threshold for effects of the test item on daphnid reproduction under the test conditions was 6.66 mg/l (NOEC) and 14.6 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 (separation factor 2.3). The effects on reproduction were evaluated based on the reproduction per introduced parent animal, since this parameter is the ecologically most relevant response variable and is required by the OECD test guideline 211 (2012), when a significant trend in mortality is detected. 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 long-term toxicity to fish is evaluated by considering data on 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. 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). 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 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 similar substance 1 -MSA.
The study conducted on the similar 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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