Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Based on a study performed according to OECD guideline 414, a NOAEL for maternal and developmental toxicity of 30 mg/kg bw/day was determined. No specific compound related teratogenic effects were observed in this teratogenicity study.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
30 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Administration of hydroxyethyl-p-phenylenediamine sulfate by oral gavage to mated female CRL:(WI)BRWistar rats during gestation day 6 -20 at dose levels of 0, 10, 30, 70 mg/kg bw/day revealed a NOAEL of 30 mg/kg bw/day for maternal and developmental toxicity. No specific substance related teratogenic effects were observed. Based on the results of the available study performed according to OECD guideline 414, the registered substance is not classified for toxicity to reproduction/teraogenicity.

Additional information

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