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EC number: 201-162-7
CAS number: 78-96-6
The test substance is not considered as hazardous for the environment. Therefore, a chronic test in fish is not provided.
The long-term toxicity to fish was
estimated using the model ECOSAR v1.11 implemented in EPISuite v4.11
(chronic value = 327 mg/L). The substance was within the applicability
of the estimation model; but as long-term prediction by the model has
been developed based on a small data pool (training set: n < 5), the
modeled results have a high uncertainty.
In addition, the ACR approach
according to ECETOC (2003, Report no. 91) results in NOECs greater than
1 mg/L, based on the effect data of the acute toxicity study (BASF AG,
1987; report no. 10F0268/875180).
In Annex IX Section 9.1.6 column 2 of
Regulation (EC) No 1907/2006, it is laid down that long-term toxicity
testing on fish shall be proposed by the registrant if the chemical
safety assessment indicates the need to investigate further the effects
on fish. According to Annex I of this regulation, the chemical safety
assessment triggers further action when the substance or the preparation
meets the criteria for classification as dangerous according to
Directive 67/548/EEC or Directive 1999/45/EC or CLP-Regulation (EC) No
1272/2008 or is assessed to be a PBT or vPvB.
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
In Annex XI Section 3, it is laid down that
testing in accordance with sections 8.6 and 8.7 of Annex VIII and in
accordance with Annex IX may be omitted, based on the exposure
scenario(s) developed in the Chemical Safety Report (“Substance-Tailored
Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can
be demonstrated in the risk assessment that the manufacture and the use
of the substance do not pose an unacceptable risk for all environmental
compartments as the risk characterization ratios (RCRs) of the chemical
safety assessment are below 1 for all compartments (see Chemical Safety
Report Ch. 9, 10).
Therefore, and for reasons of animal
welfare, a long-term toxicity test on fish is not provided.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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