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EC number: 292-429-7
CAS number: 90622-29-0
CAL 145 comprises alkenes C13-14 hydroformylation products with
read-across from the chemically-similar Alchisor CAL 123 as defined in
the `Read-Across Justification Document'. Where
toxicological data exist for Alchisor CAL 123, these are representative
of the Alchisor CAL 145 substance.
Vitro Bacterial Reverse Mutation Assay: Alkenes, C11 -12
hydroformylation products, distn. residues was tested for mutagenic
activity in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and
TA100 and in Escherichia coli WP2uvrA according to OECD guideline 471and
the European Commission Annex V Test Method B13 and B14.
independent tests were conducted in triplicate in the absence and
presence of a metabolic activator (S9 mix). The first test was conducted
by the direct plate incorporation method, while the second test was
conducted by the pre-incubation method. The test item was dosed at
concentrations ranging from 17 to 5000 µg/plate in both assays. No
evidence of mutagenic activity was obtained with any strain in either
was concluded that Alkenes, C11 -12, hydroformylation products, distn.
residues was not mutagenic in strains of Salmonella typhimurium and
Escherichia coli when tested in acetone in the absence and presence of
metabolic activation. The test item was tested to the predetermined
maximum of 5000 µg per plate, at which concentration toxicity was
encountered. In addition, the test item was tested up to and beyond its
limits of solubility in the test system.
Vitro Mammalian Chromosome Aberration Test: Alkenes, C11 -12
hydroformylation products, distn. residues was assessed for clastogenic
potential in an in vitro mammalian chromosome aberration test in Chinese
hamster ovary cells. This reliable (Klimisch 1; Klimisch 2 when used for
read-across) and GLP compliant study was conducted according to OECD 473
guidelines. All the cultures treated with the test item had levels of
structural aberrations within the 95% confidence limits for a negative
response. An extra assessment of polyploidy was carried out on the
cultures treated in the absence of S9 mix and harvested at 48 h. All the
cultures treated with alkenes, C11-12, hydroformylation products, distn.
residues had levels of polyploidy within the 95% confidence limits for a
negative response. Consequently it can be concluded that alkenes,
C11-12, hydroformylation products, distn. residues was not clastogenic
when tested with Chinese hamster ovary cells in vitro.
Lymphoma Mutation Study: Alkenes, C11-12, hydroformylation products,
distn. residues (CAS No. 90622-27-8) were assayed for mutagenic
potential in the mouse lymphoma L5178Y cell line. Tests were conducted
both in the absence and in the presence of a metabolic activator (S9
mix). The study was designed to be consistent with ICH Guidelines, OECD
Guideline No. 476 and EC Directive 2000/32/EC B.17. No evidence of
mutagenic activity was obtained with alkenes, C11-12, hydroformylation
products, distn. residues in either the absence or the presence of S9
mix when the exposure period was 4 h. All such assays satisfied the
criteria required to demonstrate that results had been obtained at a
sufficiently toxic concentration of test item. It is therefore concluded
that alkenes, C11-12, hydroformylation products, distn. residues is not
mutagenic in mouse lymphoma L5178Y cells, in either the absence or the
presence of S9 mix, when tested in acetone at concentrations extending
into the toxic range.
mutagenic potential was reported for Alkenes, C11-12, hydroformylation
products, distn. residues in a range of in vitro genotoxicity studies
conducted according to REACH annex VII or VIII requirements.
accordance with REACH regulation Annex IX 8.4 column 2; 'Appropriate in
vivo mutagenicity studies shall be considered in case of a positive
result in any of the genotoxicity studies in Annex VII or VIII.' No
positive findings have been reported across the range of REACH Annex VII
or VIII in vitro genotoxicity studies for alkenes, C11-12,
hydroformylation products, distn residues. Consequently there is no
mandatory requirement any in vivo genotoxicity studies to be presented
in this dossier.
the basis of available in vitro data no genotoxic potential has been
identified for alkenes, C11-12, hydroformylation products, distn.
negative results reported inin vitrogenotoxicity assays do not
warrant the classification of Alchisor CAL 145
as a substance with genotoxic potential.Consequently
Alchisor CAL 145 is
not classified as a genotoxin under the new Regulation (EC) 1272/2008 on
classification, labelling and packaging of substances and mixtures (CLP)
or under the Directive 67/518/EEC for dangerous substances and Directive
1999/45/EC for preparations.
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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