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EC number: 201-605-4
CAS number: 85-43-8
mutation has been investigated in bacteria using strains ofSalmonella
typhimuriumandEscherichia coli, in accordance with OECD/EU
test methods. Five tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA
were used and experiments were performed both in the absence and
presence of metabolic activation, using liver S9 fraction from rats
pre-treated with phenobarbitone and betanaphthoflavone. The substance,
1, 2, 3, 6 tetrahydrophthalic anhydride (THPA), did not induce reverse
mutation in the tester strains, neither in the absence nor presence of
anhydride (THPA) has been assayed for the ability to cause chromosomal
damage in cultured human lymphocytes followingin vitrotreatment
in the absence and presence of S9 metabolic activation. Methods used
were in accordance with OECD/EU test methods. The substance does not
induce chromosomal aberrations in human lymphocytes.
anhydride was examined for mutagenic activity by assaying for the
induction of 5‑trifluorothymidine resistant mutants in mouse lymphoma
L5178Y cells afterin vitrotreatment using OECD/EU test methods.
It was concluded that the substance does not induce mutation at the TK
locus of L5178Y mouse lymphoma cellsin-vitro.
Regulation 1907/2006 (Annex VIII, 8.4 Column 2) states that appropriatein
vivomutagenicity studies should be considered in those cases of a
positive result in any of the in vitro genotoxicity studies. In vitro
investigations were negative and in vivo studies are therefore regarded
as inappropriate and not in line with current concerns regarding animal
welfare and the use of animals in scientific experiments.
Non classification is justified based on negative findings in 3 separate
and key in-vitro tests for gene mutation / mutagenicity.
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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