Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: OECD TG 401: LD50: 4500 mg/kg bw

Acute inhalation toxicity: Extrapolated from acute oral toxicity LC50: 23400 mg/m3

Acute dermal toxicity: Using route to route extrapolation LD50: >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute oral toxicity data is of sufficient quality and adequate for this dossier.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute toxicity via inhalation is based on the result of the acute oral toxicity study. This information is sufficiently adequate for the dossier.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The acute toxicity via the dermal route is based on the result of the acute oral toxicity study. This information is sufficiently adequate for the dossier.

Additional information

Acute oral toxicity

In an acute oral toxicity study, conducted using a protocol similar to OECD guideline 401 (non-GLP), undiluted test substance was administered via oral gavage to fasted Wistar rats (five males + five females/dose) at dose levels of 3.18, 3.96, 5.00 and 6.30 mL/kg. The animals were sluggish soon after administration. In the higher dose groups mortality was observed within 24 hours of dosing, while no mortality was observed after 7 days. Necropsy did not reveal any pathological effects. The LD50 was 4.21±1 mL/kg bw (4500 mg/kg bw) both for the 24-hour and 7-day observation period.

Acute inhalation toxicity

Using route to route extrapolation the inhalation toxicity can be derived as follows: an oral LD50 of 4500 mg/kg bw can be roughly converted into > 23400 mg/m3 (ECHA's CLP guidance, section, 3.1.3.3.5, 2017, using the formula: 1 mg/kg bw = 0.0052 mg/L/4h). In the present case 100% oral and inhalation absorption is used. The maximum saturated vapour pressure for the substance is 2.95 mg/m3 (0.028 x 256 MW (mg/mol)) / (8.3 (R, gas constant) x 293 (°K)). This means that the substance cannot reach a concentration higher than 2.95 mg/m3. Therefore, an LC50 for inhalation cannot be reached and no classification and labelling is needed for the acute inhalation route.

Acute dermal toxicity

The acute dermal toxicity is determined by read across from the oral route resulting in >2000 mg/kg bw, because acute dermal toxicity does not exceed the acute oral toxicity.

Justification for classification or non-classification

Based on acute toxicity information for all routes classification for acute toxicity is not warranted in accordance with EU CLP (EC 1272/2008 and its amendments).