Registration Dossier
Registration Dossier
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EC number: 266-564-7 | CAS number: 67075-37-0
Endpoint summary
Administrative data
Description of key information
The test substance is with high probability acutely not harmful to aquatic organisms.
Additional information
The test substance is with high probability acutely not harmful to aquatic organisms.
The inhibition of the degradation activity of activated sludge is not anticipated when introduced in appropriate low concentrations.
The test substance belongs to the category of perylene pigments as indicated by its chemical core structure. Based on this structure and the chemical and biological stability of perylene pigments under environmental conditions, data from structural analogue perylenes can be used to cover this endpoint required under REACh if no data for the original test substance is available.
The acute toxicity to fish was examined in a GLP guideline study according to JIS K 0102-1974 item 55 with the test species Oryzias latipes [BASF AG 1989]. The test substance was tested as dispersion (10.5% dye, 20% Cremophor RH 40, 70% bidistilled water). At test termination after 96 h, a LC50 of > 1050 mg/L based on nominal concentration of dye was determined.
A study on the toxicity of the analogue substance CAS 81-33-4 to Daphnia magna has been conducted according to OECD guideline 202 following a static test system setup [BASF SE, 2012]. At test termination after 48 h no toxicity was observed up to the limit of solubility of the test substance (EC50 > 0.0065 mg/L; measured).
The acute toxicity of the test substance to aquatic invertebrates has been examined in a GLP guideline study according to EEC Directive 92/32/EEC. The test animals of the species Daphnia magna were exposed to the test substance for 48 h in a static test system set up. At test termination an EC50 > 100 mg/l was determined [BASF AG, 1998]. Similar results were obtained for Perylen Schwarz/Black I (EC 479-300-2) and Perylen Schwarz/Black II (EC 475-310-6) were toxicity to Daphnia magna was examined in 48 hour static limit tests according to OECD guideline 202, respectively. At test termination an EC50 of > 100 mg/l based on nominal test substance concentrations was determined, respectively (BASF AG 2005, 2006).
The toxicity of the analogue substance CAS 4948-15-6 on aquatic algae was investigated in a GLP guideline study according to OECD 201 with Pseudokirchneriella subcapitata [BASF SE, 2012]. The substance had no observable inhibitory effect on algae growth up to its saturation limit in the test media and under test conditions. The EC50 value (based on growth rate after 72 h of exposure) was determined to be > 100 mg/L (nominal). The inhibiting abilities of Perylen Schwarz/Black I (EC 479-300-2) and Perylen Schwarz/Black II (EC 475-310-6) to Pseudokirchnerella subcapitata were examined in GLP studies according to OECD guideline 201, respectively. After 72 h the EC50 value for Perylen Schwarz/Black I and Perylen Schwarz/Black II was determined to be > 100 mg/L based on the nominal concentration of the test substances (BASF AG 2006). No effect was observed up to the solubility limit of the test substance in water.
The acute toxicity of the analogue substance CAS 81-33-4 to aquatic plants has been examined in a GLP guideline study according to OECD 221 with the test species Lemna gibba [BASF SE, 2012]. At test termination after 7 d, an ECr50 > 0.007 mg/L (measured) relating to growth rate (frond rate and dry weight, respectively) was determined.
The changes in the respiration rate of activated sludge in presence of the analogue perylenes (CAS 4948-15-6, CAS 81-33-4, CAS 128-69-8) were investigated in three guideline studies according to OECD 209 and ISO 8192, respectively, with activated sludge as inoculum. At test termination after 30 minutes effect concentrations > 700 mg/L (nominal) were determined [BASF AG 1998; BASF AG 1999; BASF AG 1986]. Additionally, several oxygen consumption tests which were conducted according to ROBRA (DIN 38412, part 27) are available for the toxicity assessment. The bacteria Pseudomonas putida was exposed to different test concentrations of the following analogue substances: CAS 3049-71-6, CAS 5521-31-3 and CAS 128-69-8 [BASF AG 1991; BASF AG 1990; BASF AG 1986]. After an exposure period of 30 minutes the lowest determined effect concentration was 1250 mg/L (nominal).
All tests were run with concentrations above the water solubility of the test substance and its analogues, respectively. Thus, no effects in the range of the water solubility of the substance were determined.
The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Therefore, and for reasons of animal welfare long-term toxicity testing in fish and aquatic invertebrates is not provided.
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