[R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol

Endpoint summary

Description of key information

In an acute oral toxicity study (OECD 401) with pseudoephedrine hydrochloride, a structural analogue of [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol, the LD50 was determined to be ca. 1000 and 464 mg/kg bw for male and female rats, respectively. After correction for molecular weight the LD50 is determined to be 804 and 373 mg/kg bw for male and female rats, respectively..

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

373 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

No studies on the acute oral toxicity of [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol were available. However, Article 13 of REACH states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i.e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across. One acute oral toxicity study is available for the structural analogue pseudoephedrine hydrochloride.

In an acute oral study (similar to OECD Guideline 401) 5 male and 5 female Wistar rats were dosed with 316, 464, 681, and 1000 mg/kg bw (BASF 1986). In the highest dose group, 3/5 males died and in the lower dose groups no mortality occurred, thus the LD50 for males was determined to be ca. 1000 mg/kg bw. In female rats no mortality occurred in the lowest dose group, but 2/5, 1/5, and 1/5 animals died in the 464, 681, and 1000 mg/kg bw dose group. A LD50 of ca. 464 mg/kg bw was therefore reported for female animals, although 50% mortality was not observed in any female dose group. Based on the clinical signs females seemed to be more sensitive compared to males: while in the 464 mg/kg bw dose group the males were only excited, the females showed dyspnea, excitation, staggering and poor general state. Nonetheless a clear LD50 could not be determined. Therefore, the dose at which 2 out of 5 females died has been selected as LD50 as a conservative approach. After correction for molecular weight the LD50 is determined to be 373 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
There is one acute oral toxicity study available for a structural analogue of [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol. The study is sufficiently adequate for this endpoint.

Justification for classification or non-classification

Pseudoephedrine hydrochloride is a structural analogue of [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol. For pseudoephedrine hydrochloride an oral LD50 in rats of 464 mg/kg bw for females and 1000 mg/kg bw for males was determined. After correction for molecular weight, the LD50 is 373 mg/kg bw. Therefore [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol has to be classified for Acute toxicity Cat 4: H302: Harmful if swallowed in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and Xn R22: Harmful if swallowed in accordance with EU Directive 67/548 (DSD).