Registration Dossier

Administrative data

Description of key information

The testing of acute oral toxicity 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. 
A study was performed in accordance with the OECD Guidelines for Testing of Chemicals (2009) No. 403 “Acute Inhalation Toxicity” and was designed to comply with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008, with the exception that only six animals (three males and three females) were utilized during the “limit test”.
According to column 2 of REACH Annex VIII, section 8.5 (Acute toxicity) was not carried out the test of acute dermal toxicity (8.5.3) by reason that inhalation exposure by dust of the test material was more probable than exposure by dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
5.15 mg/m³

Additional information

Both of the tests signalise low acute toxicity the test item:

LD50 > 2000 mg/kg bw (rat oral)

LC50 > 5.15 mg/l (rat, inhalation, 4 h)

Justification for classification or non-classification

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 both oral and inhalation, and has no obligatory labelling requirement in this respect.