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EC number: 947-313-7
CAS number: -
Based on read-across from experimental GLP
studies performed on the analogue substance Labdanum gum,
the key ecotoxicity values of the registered substance are as follow:
Invertebrates: 48-h EL50 > 100 mg test material/L
algae: 72-h ErL50 >
1000 mg test material/L
these results, the acute EL50 are
higher than 1 mg/L.
the registered substance would
not be classified as acute 1 to aquatic organisms in
accordance with the classification of the CLP.
registered substance is a Natural Complex Substance (UVCB).
Toxicity studies on aquatic organisms for
the registered substance were not available for annex VII endpoints.
However, two experimental studies performed on an analogue substance
(Labdanum gum) in order to assess its toxicity to aquatic invertebrates
and to freshwater algae were available. These studies on Labdanum gum
were performed under GLP conditions using Water Accommodated Fractions,
in compliance with OECD 201 and 202 guidelines, as well as the “Guidance
document on aquatic toxicity testing of difficult substances and
mixtures” (OECD No. 23). In addition, these studies have been reviewed
and were considered reliable. Indeed, they respected the requirements of
both guidelines and the respective validity criteria were fulfilled.
Therefore, it has been decided to use the
results from these two studies for the registered substance. The
read-across justification can be found in the related iuclid study
the dataset, short-term toxicity to fish was not provided since the
tonnage band (1 -10 tonnes/year) does not require that endpoint.
CLP Classification proposal
It is proposed to compare submission
substance dataset to CLP environmental criteria laid down in CLP
Regulation (including 2nd Adaptation to Technical Progress, Com Reg No
Acute aquatic hazard:
not classified. Reasoning: lowest E(L)C50 higher than 1 mg/L.
not classified. Reasoning: adequate chronic toxicity data are not
available, lowest acute E(L)C50 value higher than 100 mg/L.
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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