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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23.11.2009 - 8.12.2009
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
Slimes and Sludges, blast furnace and steelmaking
EC Number:
EC Name:
Slimes and Sludges, blast furnace and steelmaking
Cas Number:
Molecular formula:
not applicable
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

Test animals

Details on test animals or test system and environmental conditions:
- Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 8-10 weeks
- Weight at study initiation: see Table No. 1
- Fasting period before study: 20 hours
- Housing: animal room with monitoring conditions – 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): ST 1 BERGMAN – standard pelleted diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

- Temperature (°C): 22±3°C, permanently monitored
- Humidity (%): 30-70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Administration / exposure

Route of administration:
oral: gavage
olive oil
Details on oral exposure:
- Amount of vehicle (if gavage): 1 ml/100 g bw
- Lot/batch no. (if required): 4683401
2000 mg/kg
No. of animals per sex per dose:
6 rats (F) per dose 2000 mg/kg bw
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the first day twice (30 minuts and 3 hours after application), 2nd-14th day twice (morning and afternoon)
- Necropsy of survivors performed: yes
- Other examinations performed: changes in skin and fur, eyes, visible mucous membranes, behaviour of animals, somatomotor activity, reactions to stimuli, and presence of lacrimation, salivation and discharge from nostrils, function of respiratory, digestive and urogenital system.

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
0 dead animals
Clinical signs:
other: 30 minuts: gibbous posture 3 hours: gibbous posture, piloerection, in some cases increased response to stimuli 2nd-14th day: no clinical signs of intoxication
Gross pathology:
Any tested animals had no pathologic changes.

Any other information on results incl. tables

Table No. 1: Individual body weight - 2000 mg/kg (steps No. 1 and No. 2)

dose (mg/kg) (step No.) animal No. body weight (g) body weight gain (g)
before application 8 days post application 15 days post application 0-8 days post application 8-15 days post application
2000(1) 1 170.31 203.04 222.17 32.73 19.13
2 154.85 184.37 200.53 29.52 16.16
3 153.79 189.69 207.48 35.90 17.79
mean 159.65 192.37 210.06 32.72 17.69
SD 9.25 9.62 11.05 2.60 1.21
2000(2) 4 157.19 185.52 196.43 28.33 10.91
5 154.83 181.79 203.33 26.96 21.54
6 166.43 203.67 212.18 37.24 8.51
mean 159.48 190.33 203.98 30.84 13.65
SD 6.13 11.71 7.86 4.56 5.66

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information Criteria used for interpretation of results: EU
According to the study results the value of LD50 of the test substance, Slimes and Sludges, blast furnace and steelmaking, (in female rats) is higher than 2000 mg/kg of body weight.
Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance,Slimes and Sludges, blast furnace and steelmaking,after a single oral administration to Wistar rats.

The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

The test substance wasadministered in a single dose as suspension in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats.

The dosing was performed sequentially in two groups of three females: group No. 1 - first step using the startingdose of 2000 mg/kgofbody weight and group No.2 - second step using the same dose.

The test substance administered at thedose of 2000 mg/kgcaused no death of animals.  

Clinical signs of intoxication (gibbous posture) were observed 30 minutes after application and 3 hours after application clinical signs of intoxication (gibbous posture, piloerection, increased response to stimuli) were observed in all six animals. 24 hours after application all animals were without clinical symptoms.

No pathologic macroscopic changes were diagnosed during pathological examination.

According to the study results the value ofLD50of the test substance for female rats is higher than 2000 mg/kg of body weight.

The classification of the test substance toxicity was performed according to the Directive 67/548/EEC, Annex VI. part 3.1.5. and 3.2.

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substanceSlimes and Sludges, blast furnace and steelmaking did not fallinto any of quoted categories of toxicityandhasno obligatory labelling requirementin this respect.