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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

DIPA did not cause gene mutations in Salmonella typhimurium (2 Ames tests) or in Chinese hamster ovary cells (CHO/HGPRT), nor were chromosomal aberrations induced in rat lymphocytes. All studies were performed in the absence and presence of metabolic activation, according to OECD and EPA guidelines. Thus, DIPA is not considered to be genotoxic.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

No information available.

Additional information

DIPA was tested in the Ames reverse mutation assay using S. typhimurium strains TA98, TA100, TA1535 and TA1537 at 100 to 10000 µg/plate with and without metabolic activation. DIPA was not associated with reverse mutations in any of the strains tested. Cytotoxicity was observed at the highest dose tested (Mortelmans, 1986; RL2).

DIPA was also evaluated in the Salmonella/mammalian-microsome bacterial mutageniaty assay (Ames test) using a pre-incubation modification of the standard assay (1994, RL1). The test was conducted in the presence and absence of an externally supplied metabolic activation system (S-9) using Salmonella typhimuriurn tester strains TA98, TA100, TA1535, and TA1537. The concentrations of the test material assayed ranged from 100 to 5000ug/plate. The test material did not induce a positive increase in the number of histidine revertant colonies in any of the test strains either in the presence or absence of the external metabolic activation system. Hence, diisopropanolamine was classified as negative in the Ames test under the experimental conditions used.

Induction of gene mutations in mammalian cells was investigated in an HGPRT assay (according to EPA/OECD guidelines, under GLP) using Chinese hamster ovary (CHO) cells at 313 to 5000 µg/ml, with and without metabolic activation. The results indicate that DIPA did not cause gene mutations in this assay. No cytotoxicity was observed (1994; RL1).

DIPA tested at 78.1 to 5000 µg/ml did not induce significant increases in chromosomal aberrations using rat lymphocytes with and without metabolic activation (according to OECD guideline 473, under GLP, 1994, RL1).

No in vivo genotoxicity study is available for DIPA, but is also not considered necessary since no genotoxic properties were revealed in the vitro studies.

Justification for classification or non-classification

Based on the results of the in vitro genetic toxicity studies, DIPA does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.