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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

In order to establish the maximum tolerated concentrations of the test substance for administration to dosed animals in a chronic study, a subchronic toxicity study was conducted with Fischer-344 -rats of both sexes.
The concentrations used were: 0.03; 0.1; 0.3; 1.0 and 3.0 %(ca. 20, 67, 200, 667 or 2000 mg/kg/d) . The dosed dietary preparations were administered for 8 weeks.
Deaths were recorded for all groups of rats receiving concentrations of 0.3 % or more (no Nr. of animals given).
Mean body weight depression was approximately 19 and 9 %, respectively, in males and females dosed with 0.1 % of test substance. No effect level based on this study. Only bw. And mortality examined.
The dose chosen as highest concentration of test substance in the rat chronic bioassay was 0.1 %.
Additionally a subchronic toxicity study was conducted with B6C3F1 mice of both sexes.
The concentrations used were: 0,03; 0,1; 0,3; 1,0 and 3,0 %(ca. 43, 143, 429, 1429 or 4286 mg/kg/d) . The dosed dietary preparations were administered for 8 weeks.
Deaths were recorded for all groups of mice receiving concentrations of 0,3 % or more (no Nr. of animals given).
Mean body weight depression was approximately 22 and 3 %, respectively, in males and females dosed with 0,3 % of test substance.
Males receiving 0,1 % experienced mean body weight depression of approximately 3 %.
The highest concentration of test substance in the mouse chronic bioassay was 0,2 % (NCI 1978).
25 female Wistar-rats received 1,5 -naphthylenediamine by gavage (dose: 0; 2; 10; 50 mg/kg bw.) daily from day 6 to day 15 of gestation.
From 10 mg/kg bw./day the food consumption and weight gain were influenced.
In the 50 mg/kg dose group sporadic heightened urine excretion was observed and additionally in one animal an increased water consumption detected.
No meaningfull pathological-anatomical findings and no mortalities were observed.
From 10 mg/kg bw/day a marginal diminuated weight of fetuses was identified.
The NOAEL f...

Key value for chemical safety assessment

Additional information

Justification for classification or non-classification