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Key value for chemical safety assessment

Effects on fertility

Additional information

No data are available to specifically evaluate the reprotoxic effect of the target substance or its sulfate form. During the 90 days toxicity study performed on 1,4-diamino-2methoxymethylbenzene sulfate, male and female reproductive organs of rats were observed. No effects were reported, thus no effect on the reproductive performance could be expected.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Additional information

Administration of Methoxymethyl-PPD-Sulfate by the oral route during organogenesis (Day 6 to 19 of gestation) at dose level of 0, 10, 30 and 90 mg/kg bw/day resulted in NOAEL of 30 mg/kg bw/day for maternal toxicity (based on a transient reduction in mean body weight gain and food consumption ). The NOAEL: 30 mg/kg/bw for methoxymethyl-PPD-Sulfate, corresponds to 30 x 0.61 = 18.3 mg/kg bw for methoxymethyl-PPD-base using the conversion factor of 0.61.

The NOAEL for developmental toxicity was 90 mg/kg bw/day. No data are available to specifically evaluate the reprotoxic effect of the target substance or its sulfate form. During the 90 days toxicity study performed on 1,4-diamino-2methoxymethylbenzene sulfate, male and female reproductive organs of rats were observed. No effects were reported, thus no effect on the reproductive performance could be expected.

The NOAEL for developmental toxicity was 90 mg/kg bw/day for sulfate and corresponds to 90 x 0.61 = 55 mg/kg bw  for methoxymethyl-PPD-base.

Justification for classification or non-classification

Additional information

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