Registration Dossier

Administrative data

Description of key information

A single oral gavage treatment with Intermediate 36 did not cause any test article related adverse effects, all findings were typical for rats following euthanasia and exsanguination. According to OECD Guideline No. 423, Intermediate 36 was ranked into ‘Category 5 or Unclassified’ (at least GHS Category 5). The LD50(oral) is determined to be > 2000 mg/kg bw. A study on acute dermal as well as on acute inhalative toxicity was not performed as not required according to European Community Regulation 1907/2006 Annex VII, Section 8.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Under the conditions of the present study, a single oral administration of the test item Intermediate 36 at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects. According to OECD Guideline No. 423, Intermediate 36 was ranked into ‘Category 5 or Unclassified’ (at least GHS Category 5) in terms of Globally Harmonized Classification System as described in this guideline.

Justification for classification or non-classification

As under the conditions of the present study, a single oral administration of Intermediate 36 at the dose level of 2000 mg/kg bw did not cause any treatment related adverse effects, the substance was ranked into ‘Category 5 or Unclassified’ (at least GHS Category 5) in terms of Globally Harmonized Classification System.