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EC number: 941-360-7 | CAS number: -
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No tests are available for the substance under registration. However, the main constituent Acetophenone is regarded as most relevant for the evaluation of the multi consituent substance. Therefore, the results of the test with Acetophenone were presented. The procedure laid down in the CLP regulation (1272/2008/EG) to base the classification and labelling on the available data and classification of the known main and relevant constituents was used. Based on this evaluation no further testing is indicated to be neccessary.
'With regard to the main constituent Acetophenon:
Only one valid study dealing with the acute toxicity of acetophenone towards Daphnia magna is available. In the frame of determining body burden, also the 48 h LC50 of Daphnia magna exposed to acetophenone was determined. In the static test, a 48 h LC50=528 mg/L (4.4 mmol/L; nominal) was determined. The study is documented in sufficient detail and regarded as valid.
Key value for chemical safety assessment
Additional information
No tests are available with the registered substance. The procedure laid down in the CLP regulation (1272/2008/EG) to base the classification and labelling on the available data and classification of the known main and relevant constituents was used.
Table Main constituents of the registered substance and other relevant substances that were analytically determined and respective data onShort term toxicity testing on aquatic invertebratesand classification with regard to hazards to the aquatic environment according to CLP regulation (1272/2008/EG)
Substance (other names), main constituents marked in bold letters |
CAS |
LL (%) |
UL (%) |
typical concentration (%) |
Short term toxicity testing on aquatic invertebrates |
Classification with regard to environmental hazards to the aquatic environment |
(E)-1,4-diphenyl-2-butene-1,4-dione (trans-1,2-Dibenzoylethylene) |
959-28-4 |
3 |
10 |
5.5 |
no data |
not classified |
1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene (dim. A-MS) |
6362-80-7 |
1 |
2.2 |
1.9 |
LC50D. magna(48 h) = 0.057 mg/L (based onECHA-Information on registered substance) (Note 1) |
acute aquatic tox cat 1 H400 |
2-phenylpropan-2-ol (DMPC) |
617-94-7 |
0.5 |
5 |
1.6 |
no data |
not classified |
acetophenone(Acvph) |
98-86-2 |
40 |
80 |
69 |
LC50D. magna,(48 h)= 528 mg/L |
not classified |
cresol |
1319-77-3 |
0.2 |
4 |
0.71 |
p-cresol EC50: (48 h):7.7mg/LDaphnia magna(Kuehn et al., 1989) m-cresol: LC50 (48 h) > 99.5 mg/LDaphnia pulicaria(DeGraeve et al.,1980) o-cresol: LC50: (48 h): 15.7 mg/LDaphnia magna(CantonandAdema)(based onECHA-Information on registered substance) |
not classified |
hydratropaldehyde(Phenylpropionaldehyd-2) |
93-53-8 |
5 |
20 |
8.5 |
no data |
not classified |
phenol |
108-95-2 |
0.1 |
0.5 |
0.11 |
EC50,Ceriodaphnia dubia, 48 h = 3.1 mg/L (SDS, Domo) |
not classified |
β,β-dimethylstyrene |
768-49-0 |
0.2 |
5 |
1.2 |
no data |
not classified |
unknown constituents |
|
1 |
15 |
11.5 |
no data |
not classified |
Underlined L(E)C50 values were used to calculate the L(E)C50mix (see details below).
Note 1: the used test system is evaluated as not appropriate because test was done using the solvent N,N-dimethylformamide to get test item soluble. Instead the water accommodative fraction method should had been used. Therefore, this test is classified as not reliable.
Data on short term toxicity on invertebrates is available for the main constituent Acetophenon (with up to 80% concentration) and the impurities 1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene, cresol and Phenol. For the impurity isomeric mixture cresol (CAS 1319-77-3) data is available for the isomers o-, m-, p-cresol which are considered suitable to assess the isomeric mixture cresol (based on available disseminated information by ECHA). No data on short term toxicity on invertebrates is available for (E)-1,4-diphenyl-2-butene-1,4-dione and hydratropaldehyde and the impurities 2-phenylpropan-2-ol2-phenylpropan-2-ol and β,β-dimethylstyrene β,β-dimethylstyrene.
The environmental hazards (Hazardous to the aquatic environment) assessment is based on available information on the hazards for each of the containing substances. The procedure laid out in section 4.1.3. (Classification criteria for mixtures) of annex I of the CLP-Regulation (1272/2008 (EC)) was used. Data are available for most of the relevant constituents and impurities, however for a minor but however relevant amount (concentration) of constituents data are missing. Data is available for one constituent that is classified as Acute 1 and others that are not classified. For this part of the mixture (multi constituent substance) the combined toxicity is calculated using the additivity formula. For final classification according to CLP regulation the summation method (4.1.3.5) was applied.
The additivity formula for acute aquatic toxicity under section 4.1.3.5.2 of annex I, CLP regulation was applied to calculate the L(E)C50mix for 71.7% of the multi constituent substance under registration:
The total concentration of the constituents and impurities with unknown toxicity is 28.3 % (based on typical concentrations).
The calculated short term L(E)C50mix (for invertebrates) of 2.1 mg/L accounts for the constituents and impurities with known toxicity (71.7 %, for the typical concentrations).
Based on the procedure laid out above a classification of the (multi constituent) substance was concluded. Thus, no further testing regarding the short term toxicity testing on aquatic invertebrates (9.1.1 Annex VII, REACH) is considered appropriate. By using this above procedure this adaption to the short term toxicity testing on aquatic invertebrates is in compliance with the general rules contained in Annex XI, REACH.
References
Kuehn et al., Water Res. 23(4), 495-499, 1989 (cited in ECHA-website for registered substance)
DeGraeve et al., Arch. Environ.Contam. Toxicol. 9: 557-568, 1980 (cited in ECHA-website for registered substance)
Canton, JH, Adema, DMM, Hydrobiologia 59(2), 135-14, 1978(cited in ECHA-website for registered substance)
ECHA: http://echa.europa.eu/information
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