Registration Dossier

Administrative data

Description of key information

The available data for C12-C18 TMAC indicates a low acute oral toxicity (LD50 =684 mg test substance/kg bw) and dermal toxicity (LD50 = 528 mg a.i./kg bw).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
684 mg/kg bw
Quality of whole database:
One study available on substance itself. Study was conducted according to the OECD guideline as well as in compliance with GLP.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
528 mg/kg bw
Quality of whole database:
One reliable study conducted according to the OECD guidelines.

Additional information

Oral

An OECD 401 study was performed to assess the acute oral toxicity of C12-C18 TMAC in Sprague-Dawley rats. Groups of 10 fasted animals (five males and five females per dose except for five males in the highest dose) were administered 0, 512, 620, 750 and 908 mg/kg bw of the test substance (purity not specified) via the oral route. The animals were observed for 14 days after dosing and then sacrificed and subjected to gross pathological examination. There was no mortality in the 512 mg/kg bw group while 3 out of 10 and 7 out of 10 rats died in the 620 and 750 mg/kg bw groups, respectively. All five animals died receiving the highest tested dose of 908 mg/kg bw. The acute oral LD50of the test substance in Sprague-Dawley rats was determined to be 684 mg/kg bw with 95% confidence limits of 629−743 mg/kg bw (Naas DJ, 1987).

Dermal

An OECD 402 study was conducted to determine the acute dermal toxicity of C12-C18 TMAC in male or female albino rabbits. The test substance was applied (single application) to groups of 10 rabbits (five per sex) at dose levels of 0, 520, 1,020 and 2,000 mg/kg bw to shaved, intact skin under semi-occlusive conditions for 24 hours. Animals were observed at 1, 3 and 4 hours post-dosing. Following the 24 hour exposure period, animals were observed for mortality, clinical signs and skin response for 14 days. There was no mortality in the control or 520 mg/kg bw group. Two males died in the 1,020 mg/kg bw group while 4 males and 3 females died in the 2,000 mg/kg bw group. Under the conditions of the test, the acute dermal LD50for male and female albino rabbits was found to be 1,600 mg/kg bw (95% confidence limits of 1,200 – 2,100 mg/kg bw) (Naas DJ, 1988) or equivalent to 528 mg a.i./kg bw.


Justification for selection of acute toxicity – oral endpoint
One study available on substance itself. Study was conducted according to the OECD guideline as well as in compliance with GLP.

Justification for selection of acute toxicity – inhalation endpoint
The substance is a waxy solid with a low vapour pressure which forms clumps at room temperature. Due to it’s physical state and physical chemical properties it is unlikely that this substance will form inhalable dust, mist or fumes during normal processing and use conditions. In case inhalable forms of the substance are created under particular conditions (e. g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for selection of acute toxicity – dermal endpoint
One reliable study conducted according to the OECD guidelines.

Justification for classification or non-classification

The acute toxicity data (oral and dermal LD50of 684 mg test substance/kg bw and 528 mg a.i./kg bw, respectively) suggests a R22 (harmful if swallowed) and R21 (harmful in contact with skin) classification according to EC DSD criteria (67/548/EEC) and Category 4, H302: Harmful if swallowed and Category 4, H311: toxic in contact with skin classification according to EC CLP criteria (EC 1272/2008) for oral and dermal routes, respectively.