Slimes and Sludges, blast furnace and steelmaking

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: Assessment from available information

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Test material

Test material information

Constituent 1

Reference substance name:

Slimes and Sludges, blast furnace and steelmaking

EC Number:

266-006-2

EC Name:

Slimes and Sludges, blast furnace and steelmaking

Cas Number:

65996-73-8

Molecular formula:

not applicable

IUPAC Name:

Sludges steelmaking

Details on test material:

- Physical state: solid
- Composition of test material, percentage of components: Fe (total) 54.29% (mainly as oxides), CaO 10.17%, Zn 5.25%, MgO 4.32%, C 2.06%, SiO2 1.64%, Mn 0.69%, K2O 0.126%, Na2O 0.239%, Al2O3 0.16%
- Lot/batch No.: 21.10.2009
- Expiration date of the lot/batch: unlimited
- Stability under test conditions: unlimited
- Storage condition of test material: stored in PE container at room temperature

Results and discussion

Any other information on results incl. tables

Acute studies

The substance, Slimes and Sludges, blast furnace and 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 effects - gibbous posture only 30 minutes after application and piloerection and increased response to stimuli 3 hours after application in all animals 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 (increased respiratory rate, hunched posture, piloerrection and wet fur - till the 4th day after exposure) were noted after 4-hour nose exposure of the substance at the concentration of 5.12 mg/l.

After single application on skin of rabbit, no irritant or corrosive effects were observed. The substance is not irritant. No symptoms of systemic toxicity were observed in rabbits after application on skin.

Examination of eye after single application of substance to the conjunctival sac demonstrated, that Slimes and Sludges, blast furnace and steelmaking, is not irritating for eye of rabbit; the changes observed were reversible (redness and chemosis of conjunctivae and lacrimation - these changes faded away till the 2nd day of study). No corrosive effects were observed on eyes of rabbit and no clinical signs of systemic intoxication were detected. 

The substance, Slimes and Sludges, blast furnace and steelmaking, elicited negative response after topical application to the mouse ear in LLNA. No clinical signs of systemic intoxication were detected in study of sensitization.

Negative results in the micronucleus test after single per oral application indicate that, the test item Slimes and Sludges, blast furnace and steelmaking, does not produce micronuclei in immature erythrocytes in bone marrow of rat.

    

Long-term studies

The oral administration of the substance, Slimes and Sludges, blast furnace and steelmaking, to rats by gavage for a period of 28 consecutive days at dose levels 160, 400 and 1000 mg/kg/day affected haematological parameters. Parameters were significantly affected by treatment at the dose level 1000 mg/kg/day. The haematology examination detected significant irreversible effect on red blood cells parameters in both sexes of all treated groups - the increased value of hematocrit and haemoglobin were recorded in both sexes. Males showed the irreversible increased value of mean corpuscular volume and females showed the increased value of total erythrocyte count after application period.

The biochemical examination revealed significant differences in both sexes with a dose-related trend. A significantly decreased concentration of albumin together with dose-related decreased value of total protein was recorded in both sexes but markedly in males. Markedly decreased value of creatinine with dose-dependent manner was recorded in both sexes. The concentration of cholesterol was decreased at the highest dose of males and inorganic phosphorus was increased in all treated groups of females. After the recovery period, changes were recorded only in females: significantly decreased value of urea, increased concentration of cholesterol and insignificantly decreased activity of AST. These changes together with dose-dependent decreased weight of liver can be indications of affection of liver metabolism. Pathological examination revealed vacuolation of hepatocytes in most of males and females at the highest dose level. These changes are an indication for hepatocellular damage.

The biometry of organs also detected decreased weight of spleen in both sexes with dose-dependence in females.

The application of the test substance caused temporary colouring of the chyme and had negative effect on digestive tract.

In Reproduction/Developmental Toxicity Screening Test the following dose levels: 160, 400 and 1000 mg/kg/day were administered.

The negative influence of the test substance treatment expressed mainly at the highest dose level (limit dose): decreased body weight of parental females, impaired sperm quality of parental males and changes of microscopic structure of reproduction organs (testes) in parental males were observed.

The test substance administered at the highest dose level had negative influence on reproduction parameters of parental females (number of pregnant, number of females achieving pregnancy, average number of pups, sex ratio, average weight of litter, corpora lutea, implantation).

Durations of mating and pregnancy, average body weight and postnatal development of pups were unaffected by the test substance treatment.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: see Conclusions
Only mild systemic effects 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 5.12 mg/l.
After single application on skin of rabbit, no irritant or corrosive effects were observed. The substance is not irritant. No symptoms of systemic toxicity were observed in rabbits after application on skin.
Examination of eye after single application of substance to the conjunctival sac demonstrated, that Slimes and Sludges, blast furnace and steelmaking, is not 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 test substance elicited negative response after topical application to the mouse ear in LLNA. 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 160, 400 and 1000 mg/kg/day affected haematological parameters. Parameters were significantly affected by treatment at the dose level 1000 mg/kg/day. The haematology examination detected significant irreversible effect on red blood cells parameters in both sexes of all treated groups. The biochemical examination revealed significant differences in both sexes with a dose-related trend. Dose-dependent decreased weight of liver can be indications of affection of liver metabolism. Pathological examination revealed vacuolation of hepatocytes in most of males and females at the highest dose level. These changes are an indication for hepatocellular damage. The biometry of organs also detected decreased weight of spleen in both sexes with dose-dependence in females. The application of the test substance caused negative effect on digestive tract.
In Reproduction/Developmental Toxicity Screening Test the following dose levels: 160, 400 and 1000 mg/kg/day were administered. The negative influence of the test substance treatment expressed mainly at the highest dose level (limit dose) was observed. The test substance administered at the highest dose level had negative influence on reproduction parameters of parental females. Durations of mating and pregnancy, average body weight and postnatal development of pups were unaffected by the test substance treatment.

Executive summary:

Evaluation of toxicokinetics of the substance Slimes and Sludges, blast furnace and steelmaking was performed. Evaluation of toxicokinetics of the substance is required according to the section 8.8.1 of Annex VII to the Directive (EC) No. 1907/2006 (REACH).

Slimes and Sludges, blast furnace and steelmaking is the complex product of oxides and elements. The main components of the test substance are the following: Fe total (54.29 % - mainly as oxides) and CaO (10.17 %).

The evaluation of toxicokinetics of the test substance was performed according to experimental data from the testing of Slimes and Sludges, blast furnace and steelmaking at CETA - VUOS.

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