Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Additional information

Justification for classification or non-classification

The Polyethylene glycol resulted to have a mutagenicity activity against Chinese Hamster epithelial liver cells (CHEL) and Chinese hamster Ovary (CHO).


However, this doesn’t reflect the real behaviour of the PEG 400 which isn’t able to cross the biological membranes. In support of this, the PEG 400 shows a negative Log Kow (-3.05) and for this systemic and local exposures are unlikely. In fact, PEG 400 is widely used in products such as cosmetics and pharmaceuticals.


Concerning the Tetrahydroxy salicylate, a read-across based on the sodium salicylate was approached. As reported in the endpoint “Genetic toxicity in vitro_THS_SOURCE”, the sodium silicate was investigated in the streptomycin dependent strains Escherichia coli B/Sd-4/1,3,4,5 and B/Sd-4/3. No evidence of mutagenicity was observed at concentrations of 0.025 - 0.3 %.