Registration Dossier

Administrative data

Description of key information

LD50 oral > 6400 mg/kg bw, no mortality observed (BASF AG, 1971)
LD50 dermal > 2000 mg/kg bw, no mortality observed (BASF SE, 2014)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
6 400 mg/kg bw
Quality of whole database:
Scientifically acceptable study report. Basic data given.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant study.

Additional information

Acute oral toxicity

In an acute oral toxicity study, groups of Gassner rats (10/sex) were given a single oral dose of the emulsified test substance at dose levels of 3200 and 6400 mg/kg (BASF AG, 1971). The animals were observed for 7 days.

No mortality was observed. The animals did not show any clinical signs. No gross internal lesions were observed during necropsy. A discriminating dose of above 6400 mg /kg was determined.

Acute inhalation toxicity

An inhalation hazard risk test was performed in principle as described in OECD guideline 403 (BASF AG, 1971). It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at 20°C. 12 young adult laboratory rats and were exposed sequentially to the vapors generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. No analytical determination of the atmosphere concentrations was performed. Group-wise documentation of clinical signs was performed over a 7 day study period. Necropsy was performed with the survivors.

No mortality was observed during the study period. No clinical signs in any of the animals was detected. The necropsy of the animals at the end of the study period did not reveal any treatment related findings. Based on the available data, a LD50 could not be determined.

Acute dermal toxicity

In an acute dermal toxicity study (Limit Test) according to OECD guideline 402, young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the test item tris(2-hydroxyethyl)methylammonium methyl sulphate (undiluted) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours (Bioassay, 2014). The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

No mortality occurred. Animals did not show any signs of systemic toxicity. Some test item-related local effects were recorded during the course of the study, that occurred within the first 6 days after administration. All animals exhibited very slight erythema (grade 1). Only one female showed scaling from day 2 until day 6 and incrustations on day 6 only. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. The mean body weight of the male animals increased within the normal range throughout the study period with one exception. In one male animal the body weight decreased during the second week, but this occurred without any clinical symptoms or any change in behavior. The body weight of the female animals only slightly increased or stagnated during the first observation week, probably due to the bandage procedure, but increased within the normal range during the second week.

Accordingly, the acute dermal median lethal dose (LD50) was determined to be above 2000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
Scientifically acceptable study report. Basic data given.

Justification for selection of acute toxicity – dermal endpoint
GLP and guideline compliant study.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies on acute toxicity are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance does not need to be classified and labelled for acute oral and dermal toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EC. The test substance cannot be classified and labelled for acute inhalation toxicity. Considering the suitability of the available data, classification and labelling for acute inhalation toxicity is not indicated.

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation EC No 605/2014. The test substance cannot be classified and labelled for acute inhalation toxicity. Considering the suitability of the available data, classification and labelling for acute inhalation toxicity is not indicated.