Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Dust, steelmaking
EC Number:
266-005-7
EC Name:
Dust, steelmaking
Cas Number:
65996-72-7
IUPAC Name:
Dust steelmaking
Details on test material:
- Physical state: solid
- Composition of test material, percentage of components: Fe total 57.64% (mainly as oxides), CaO 8.89%, Zn 4.16%, MgO 3.64%, C 0.69%, SiO2 1.56%, Mn 0.57 %, K2O 0.281%, Na2O 0.251%, Al2O3 0.18%
- Lot/batch No.: 21.10.2009
- Expiration date of the lot/batch: unlimited
- Storage condition of test material: stored in PE container at room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Age at study initiation: 8-10 weeks
- 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): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22±3°C, permanently monitired
- Humidity (%): relative humidity 30-70 %, permanently monitored
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1 ml/100 g bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 rats (F) per dose 2000 mg/kg bw
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the 1st day twice (30 mins and 3 hrs after applications), the 2nd day twice (morning, afternoon) and daily thereafter for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, macroscopic changes of organs and tissues

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
0 dead animals
Clinical signs:
in all animals:
30 minutes: no clinical signs of intoxication
3 hours: piloerection
2nd - 14th day: no clinical signs of intoxication
Body weight:
All tested animals gained weight.
Gross pathology:
Any tested animals had no pathologic changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the study results the value of LD50 of the test substance, Dust, 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, Dust, 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 was administered 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 starting dose of 2000 mg/kg of body weight and group No.2 - second step using the same dose.

The test substance administered at the dose of 2000 mg/kg caused no death of animals.

Clinical signs of intoxication (piloerection) were observed 3 hours after application 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 of LD50 of the test substance for female rats is higher than 2000 mg/kg of body weight.

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substance Dust, steelmaking did not fall into any of quoted categories of toxicity and has no obligatory labelling requirement in this respect.