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Diss Factsheets

Administrative data

Link to relevant study record(s)

Description of key information

Short description of key information on bioaccumulation potential result: 
Evaluation of toxicokinetics of the substance Dust, steelmaking was performed. Evaluation of toxicokinetics of the substance is required according to the 8.8.1 of Annex VII to the Directive (EC) No. 1907/2006 (REACH). The data used for the evaluation originated from three sources:
- Experimental data of toxicological tests (unpublished)
- Literature data obtained from internet
- Data from toxicological databases - free and commercial

Key value for chemical safety assessment

Additional information

The substance, Dust, steelmaking, was applied to laboratory animals (rat, mouse, and rabbit) during studies with different way of entry into organism (e.g. stomach, respiratory tract - nose, skin and eye).

Only mild systemic were described after single oral application of the dose level 2000 mg/kg of the substance to rats. Observed changes faded away till 24 hours after application of the test substance.

Common clinical abnormalities were noted after 4-hour nose exposure of the substance at the concentration of 5.15 mg/l.

After single application on skin of rabbit, no irritant or corrosive effects were observed.

Examination of eye after single application of substance to the conjunctival sac demonstrated, that Dust, steelmaking, is irritating for eye of rabbit; the changes observed were reversible. No corrosive effects were observed on eyes of rabbit and no clinical signs of systemic intoxication were detected. 

The substance, Dust, steelmaking, may cause skin sensitisation by skin contact (in accordance with result a mouse LLNA test). No clinical signs of systemic intoxication were detected in study of sensitization.

The oral administration of the test substance to rats by gavage for a period of 28 consecutive days at dose levels 120, 300 and 750 mg/kg/day did not cause mortality.

The haematology examination showed an effect on total leucocyte count (statistically significant increase) in males of middle dose level with irreversible effect.

Only one statistically significant effect, which was manifested in results of biochemical examination was the increase of calcium and phosphorus ions concentrations in peripheral blood. Increase of weight of liver (with dependence on dose level in males) can be indications of affection of liver metabolism but during histopathological investigation no changes of hepatocytes morphology were observed.

In Reproduction/Developmental Toxicity Screening Test the following dose levels: 100, 300 and 900 mg/kg/day were administered. The application of the test substance did not cause the death of any female or male. The test substance affected reproductive system of parental males. The test substance had probably injurious effect on sperm quality of treated males.

In Prenatal Developmental Toxicity Study the following dose levels: 1000, 400 and 160 mg/kg/day were administered. The application of the test substance did not cause the death of pregnant females. No effect of the test substance on maternal animals was observed. Test substance application did not induce external and/or visceral malformations of foetuses (permanent structural change that may adversely affect survival).Delayed development of foetuses - delayed ossification of cranial, sternum skeleton and sacral vertebrae, was detected at all dose levels. These findings related with decreased individual body weights of some foetuses. The test substance treatment evoked occurrence of variations – wavy ribs in all treated groups, so it indicates teratogenic properties of the test substance (it did cause morphologic changes of skeleton) on early prenatal development of organism in uterus.