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EC number: 701-162-1
CAS number: -
Justification for the read-across approach using
(Tetrapropylensuccinimido)-caproic acid as supporting substance:
The registration substance (Pentapropylensuccinimido)-caproic acid and
proposed supporting substance (Tetrapropylensuccinimido)-caproic acid
are homolog series of (Polypropylensuccinimido)-caproic acid. The only
structural difference is that the alkyl moiety of the registratoin
substance is composed of five propylen unit, whereas that of the
supporting substance is composed of four propylen unit. The given
structural difference is not likely to be associated with significantly
deviating chemical reactivity, thus is not likely to be associated with
significantly deviating reactivity with genetic materials.
Evaluation of the genotoxicity of the registration substance
The read-across supporting substance is not mutagenic in Ames test, not
mutagenic in HPRT test. It is however clastogenic in in-vitro chromosome
aberration test and not clastogenic in in-vivo chromosome aberration
genotoxicity of (Pentapropylensuccinimido)-caproic acid was assessed
based on the toxicity data or the read-across supporting substance
acid was tested in the in vivo cytogenetic test in bone marrow cells of
the Sprague Dawley rat. The test compound was suspended in sesame oil
and was given twice at an interval of 24 hours as oral doses of 0
(negative controls), 500, 750 and 1000 mg per kg body weight to male and
female Sprague Dawley rats. The negative control group received sesame
animals survived after treatment. No signs of toxicity were observed in
the main study.
animals were killed 24 hours after the second administration for bone
dissection of the animals revealed no test substance related macroscopic
findings. Evaluation of the slides indicated slight cytotoxicity in the
high dose group (mitotic index 6.5%) as compared with the negative
controls (mitotic index 8.0%).
increase occurred in the number of polyploid meta phases.
significant increase in the aberration rate excluding and including gaps
was observed in all dose groups as compared with the negative control.
increase in the number of chromosome aberrations after administration of
the test substance was observed.
summary, administration of (Tetrapropylensuccinimido)-capronic acid
induced cytotoxicity but not chromosome aberrations in bone marrow cells.
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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