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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity, LD50: > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Oral Toxicity

The study was performed to assess the acute oral toxicity of the Similar substance 01 following a single oral administration in the Sprague-Dawley rat. The method followed the OECD Guideline 423 (adopted 22 March 1996), EU Commission Directive 96/54/EEC method B1. No deaths occurred and no signs of systemic toxicity were noted during the study. The faeces of the females were stained orange on day 1. Necropsy did not revealed abnormalities. LD50 was > 2000 mg/kg bw (males and females).

The Similar susbtance 02 was tested for oral acute toxicity according to the Real Decree 363/1995, that is the transposition of Directive 67/548/EEC in Spanish legislation. The LD50 value is > 2000 mg/kg.

Based on the read-across principle, the results can be considered for the assessment of the registered substance.

Justification for read-across is detailed in the report attached to the IUCLID section 13.

Justification for classification or non-classification

Acute oral toxicity

According to the CLP Regulation 1272/2008/EC, 3.1.2.1 section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1:

Oral (mg/kg body weight)

Category 1: LD50 ≤ 5

Category 2: 5 <LD50 ≤ 50

Category 3: 50 < LD50 ≤ 300

Category 4: 300 < LD50 ≤ 2 000

The oral LD50 values are > 2000 mg/kg/body weight.

The substance is not classified for oral toxicity because it doesn't meet the classification criteria of the CLP regulation n.1272/2008.