Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
5 mg/kg bw/day
Effect on fertility: via inhalation route
Dose descriptor:
NOAEC
4.41 mg/m³
Effect on fertility: via dermal route
Dose descriptor:
LOAEL
25 mg/kg bw/day
Additional information

The study determined that Dusantox L is considerably cumulated in liver where it was proved after 2 hours of per
oral ingestion and the maximum value reached 8 hour after application. In study plan the highest dose of application
of Dusantox L was 75 mg/kg, but the observations identified, that males after application of substance had following
findings: higher ferocity, more often defecation and softer consistence of excrement, bristly coat, apathy, diarrhoea,
stagnancy of body weight. All described findings confirmed the adverse effect of Dusantox L in dose of 75 mg/kg already
after 30 days. According to the plan study term and findings the dosing was changed and the highest dose
decreased to 50 mg/kg. Following to the study results the NOAEL value of Dusantox L  was stated for reproduction
toxicity 5 mg/kg and LOAEL value 25 mg/kg in P -generation and NOAEL 25 mg/kg and LOAEL  > 25 mg/kg in F1 - generation.


Short description of key information:
The effects of Dusantox L on fertility were evaluated in a Two generation reproduction study (OECD 416, GLP) with rats male and female.
The developmental toxicity of test substance Dusantox L was evaluated in Prenatal developmental toxicity study (OECD 414, GLP) with rats.

Effects on developmental toxicity

Effect on developmental toxicity: via inhalation route
Dose descriptor:
LOAEC
22.04 mg/m³
Effect on developmental toxicity: via dermal route
Dose descriptor:
LOAEL
25 mg/kg bw/day
Additional information

The administration of the test substance Dusantox L affected growth,clinical status and macroscopic structure of organs in treated maternal animals. These effects were significantly manifested in the results of health condition controls and clinical observations (cachexia, anemia, secretion from nostrils and eyes, piloerrection, apathy). The weight of pregnant females was significantly decreased. During the necropsies of mothers the patologic changes in stomach and significantly lower absolute weight of pregnant uterus were found. Above mentioned changes were recorded at the highest dose level. In treated groups, increase in postimplantation losses - increased number of aborted females were recorded in treated groups with higher incidence at highest and middle dose levels. In individual examination of the foetuses decrased weight was found out especially at the highest dose level. The significant incidence of skeletal malformation was recorded at the highest dose level. The dose-dependent increased incidence of some of skeletal variations in comparison with the control group was found out in foetuses of all treated groups and could be considered as an adverse effect of treatment. In individual examination of the foetuses decrease of the weight was found especially at the highest dose level. Increased number of aborted females and related negative changes of reproduction parameters (postimplantation losses) were also recorded in treated groups with higher incidence at highest and middle dose levels.

Justification for classification or non-classification

The test substance Dusantox L is classified as Toxic for specific target organ - repeated , Cat.1 ( STOT Rep.Exp1 ) affected organ: liver and as May damage fertility or the unborn child (Reproductive toxicity, Hazard Category 1B) according to classification criteria 67/548/EEC and regulation 1272/2008/ EC. See attached expert judgement.