Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Hydroxyethyl-p-phenylenediamine sulfate was negative in the bacterial gene mutation test as well as in the in vitro gene mutation test in mammalian cells. Positive results were reported in the in vitro micronucleus test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

The clastogenic effects found in vitro were not confirmed in an in vivo bone marrow micronucleus test. Hydroxyethyl-p-phenylenediamine sulfate can be considered to have no in vivo genotoxic potential.

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

Additional information

Hydroxyethyl-p-phenylenediamine sulfate is not mutagenic.

Justification for classification or non-classification

Hydroxyethyl-p-phenylenediamine sulfate was negative in the bacterial gene mutation test as well as in the in vitro gene mutation test in mammalian cells. Positive results were reported in the in vitro micronucleus test. The clastogenic effects found in vitro were not confirmed in an in vivo bone marrow micronucleus test. Hydroxyethyl-p-phenylenediamine sulfate can be considered to have no in vivo genotoxic potential.