1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate (1:1)

Endpoint summary

Description of key information

 oral: rat, OECD 423, limit test: LD 50 > 2000 mg/kg bw (1/6 animals died at 2000mg/kg bw, possible application error), (BASF, 1998)
 inhalation: no data available
 dermal: no data available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

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

There is one reliable and relevant study available investigating the acute oral toxicity of 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate.

The study was performed to assess the acute toxicity following oral adininistration of applied a 1-Butanaminum, N,N-dibutyl-N-methyl-, methyl sulfates a solution in aqua bidest., in Wistar rats according to EC and OECD guidelines (OECD 423).

To a group of six fasted animais (three males and three females) a single oral dose of the test material preparation in aqua bidest. at a dose level of 2000 mg/kg body weight was given via gavage. Signs of toxicity were noted in 1 female animal of the 2000 mg/kg dose group comprised poor general state, dyspnoea, abdominal position, atonia and diarrhea.

In all other animals of the 2000 mg/kg dose group (3 males, 2 females) no signs of toxicity were observed. The expected body weight gain was generally observed in the course of the study. 1 female animal of the 2000 mg/kg dose group died 2 hours after application.

Necropsy findings of the animal that died comprised discolouration of all lobes of the lungs, dilatation of the caecum and liquid contents in the caecum. lt can not be excluded that the death was induced by gavage error.

No abnormalities were noted at necropsy of animals sacrificed at the end of the study.

Under the conditions of this study the median lethal dose of 1-Butannminium, N,N-dibutyl-N-methyl-, methyl sulfate after oral application was found to be greater than 2000 mg/kg for the male and female animals (BASF, 1998).

As this study is the only avaiable information, but reliable and good documented, this information is integrated as key study.

Conclusion:

Based on the information received from the acute oral toxicity study the substance is assumed to be practical non toxic as the died animial can be also traced back to a gavage application error. According to the applicant the lung findings suggest a application error, and therefore the substance is rated as not toxic as all other animals did not show any signs of toxicity.

Justification for classification or non-classification

Based on the information 1-Butanaminum, N,N-dibutyl-N-methyl-, methyl sulfates

, a classification is derived according to Regulation (EC) 1272/2008 or Directive 67/548/EEC and

the substance is classified as

- acute oral toxicity: no classification

- acute inhalation toxicity: no data

- acute dermal toxicity: no data

according to Regulation (EC) 1272/2008 or Directive 67/548/EEC.