Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
50 mg/kg bw/day
Additional information

The substance Fluidized Bed Combustion (FBC) Bottom Ash did not have effect on reproduction in parental males and females.

The negative influence on reproductive performace of males and females was detected only in (FBC) Fly Ash - the reasons are obscure.

In parental males the test substance, Fluidized Bed Combustion (FBC) Fly Ash treatment caused changes of sperm motility and microscopical structure of sperms, changes of biometry (relative weight) of testes and prostate gland, microscopical changes of testes and epididymides.Negative effect on number of corpora lutea and implantations, biometry of uterus (relative) and microscopical structure of ovaries was observed in parental females. The substance probably influenced internal environment of uterus but it had not effect on live pups after birth.


Short description of key information:
The test substances, Fluidized Bed Combustion (FBC) Bottom Ash and Fluidized Bed Combustion (FBC) Fly Ash, were tested for reproduction toxicity using the OECD Test Guideline No. 421 Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on July 27th 1995.
In Reproduction/Developmental Toxicity Screening Test the following dose levels: 50, 200 and 800 mg/kg/day were administered.

Effects on developmental toxicity

Description of key information
The test substances, Fluidized Bed Combustion (FBC) Bottom Ash and Fluidized Bed Combustion (FBC) Fly Ash, were tested for reproduction toxicity using the OECD Test Guideline No. 421 Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on July 27th 1995.Fluidized Bed Combustion (FBC) Fly Ash was tested using the method B.31, Prenatal Developmental Toxicity Study, Council Regulaiton (EC) no. 440/2008, Published in O.J. l142, 2008.
In Reproduction/Developmental Toxicity Screening Test the following dose levels: 50, 200 and 800 mg/kg/day were administered.
In Prenatal Developmental Toxicity Study the following dose levels: 160, 400 and 1000 mg/kg/day were administered.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
160 mg/kg bw/day
Additional information

In prenatal development study the reproduction parameters have been changed mostly at the middle and the highest dose level. There were decreased number of implantations, corpora lutea related with an increase of resorptions, preimplantation and postimplantation losses, abortion of two females and presence of two died foetuses.

These findings could be caused by the test substance treatment. 

Examination of foetal skeleton indicated delayed development of the skeleton (incomplete ossification of certain bones) at all dosesincluding control group.

It appears that the delayed development of foetuses in this study was not induced by the test substance treatment and could be connected with low individual body weight of foetuses. 

Other structural changes were recorded in all test groups as well as in control group.Malformations such as misshapen humerus and misshapen or fused arcus zygomaticus were found out only sporadically.Incidence of these findings was accidental and comparable with control group.

Presence of wavy ribs(undulation along the length of a rib)and misasligned sternebrae were detected mostly at the highest dose level. These findings probably could be related to treatment.

The occurrence of these structural skeletal variations and malformations could notbe considered as teratogenic effect of the test substance on early prenatal development of organism in uterus because incidence of these findings was accidental and comparable with control group.

Justification for classification or non-classification

The substance Fluidized Bed Combustion (FBC) Bottom Ash did not have effect on reproduction in parental males and females and development in pups.

The results of Reproduction/Developmental Toxicity Screening Test for Fluidized Bed Combustion (FBC) Fly Ash are not sufficient for classification. The negative influence on reproductive performace was confirmed by Prenatal development toxicity study (B.31).