Registration Dossier

Administrative data

Description of key information

Oral
In an acute oral toxicity study, the median lethal dose (LD50) of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate after oral administration was found to be greater than 5000 mg/kg body weight in rats.
Dermal
Under the conditions of a study according to OECD 402, the acute dermal median lethal dose (LD50) of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate after dermal application was found to be greater than 5000 mg/kg body weight in male and female rats.
Inhalation
no data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

There are reliable data available to assess the acute oral and dermal toxicity of the test substance.

Oral:

In an acute oral toxicity study, groups of fasted young Wistar rats (1 respectively 2 females) were given a single oral dose of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate in CMC-solution at a limit dose of 5000 mg/kg bw and observed for 14 days.

Single doses of 5,000 mg/kg body weight of test material preparations in 0.5% CMC-solution in doubly distilled water were given to three fasted female animals (stepwise procedure starting with one animal and supplementing two additional animals).

No mortality occurred. Clinical observation revealed impaired general state, dyspnoea and piloerection . Findings were observed from hour 1 until including hour 5 after administration. The body weights increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period.

Under the conditions of this study the median lethal dose of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate after oral administration was found to be greater than 5000 mg/kg body weight in rats .

Dermal:

In an acute dermal toxicity study according to OECD guideline 402, a single dose of 5000 mg/kg body weight of a test material preparation (purity: 92.4 weight-%; dose volume 10 g/kg bw) in 0.5% CMC-solution in doubly distilled water was applied in five male and five female animals to ca. 10% of the clipped skin (dorsal and dorsolateral parts of the trunk) and covered by a semi-occlusive dressing for 24 hours.

No mortality occurred. No systemic clinical observations or skin effects were noted in the animals. The mean body weights of the animals increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Under the conditions of this study, the acute dermal median lethal dose (LD50) of 1-((2-Butyloctyloxymethyl)-2-(3,4-dihydro-isoquinolinium-2-yl)ethyl)sulfate after dermal application was found to be greater than 5000 mg/kg body weight in male and female rats.

Inhalation:

no data available

Justification for classification or non-classification

Oral:

Based on the available data, the oral LD50 is > 5000 mg/kg bw in rats. Therefore, no indication is given for classification according to 67/548/EEC and Regulation (EC) No 1272/2008 (CLP, GHS), respectively.

Dermal:

Based on the available data, the dermal LD50 is > 5000 mg/kg bw in rats.Therefore, no indication is given for classification according to 67/548/EEC and Regulation (EC) No 1272/2008 (CLP, GHS), respectively.

Inhalation:

No data available.