Registration Dossier
Registration Dossier
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EC number: 500-118-7 | CAS number: 52625-13-5 1 - 12.5 moles propoxylated
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
D-Glucitol propoxylated has been tested according to OECD 471 (Bacterial reverse mutation assay, 'AMES-test') and according to OECD 473 (Chromosome Aberration Test). Both studies were performed with and without metabolic activation.
Both test gave negative findings for genetic toxicity.
In all three in vitro assays, two by direct test and the third by ‘read across’ , as permitted by Annex XI paragraph 1.5, nominally from 2,2',2''-nitrilotriethanol, propoxylated; see report from Paul Illing Consultancy Services Ltd. and Marlin Consultancy (Illing and Barratt, 2009 and 2009). The report identifies that 2,2’,2’’-nitrilotriethanol, propoxylated is the most bioavailable of the NLP polyols linked by an ether group. Since appropriate read-across data are available, no further testing on D-glucitol propoxylated is warranted. For further details concerning the grouping, consult Illing and Barratt (2009 and 2009) in Section 13.
Short description of key information:
Three in vitro mutagenicity assays were all negative. Therefore
further testing is not required.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Findings from in-vitro genotoxicity testing do not warrant classification and labelling according to GHS (EU).
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