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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

In an acute oral toxicity study (similar to OECD 401), the LD50 was determined to be ca. 316 mg/kg bw and ca. 827 mg/kg bw for females and males, respectively, resulting in an combined LD50 of ca. 527 mg/kg bw. In an acute inhalation toxicity study (OECD 403), the LC50 was determined to be >2.2 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
527 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

Five Wistar rats per sex per dose were exposed in a study similar to OECD 401 to 215, 316, 464, 681 or 1000 mg/kg bw of the test substance dissolved in water via oral gavage (BASF 1986). After an observation period of 14 days the surviving animals were necropsied. Animals that died showed general congestive hyperemia and a grey-brown broadened lobular periphery liver in some animals. No abnormalities were detected in sacrificed animals. The LD50 was determined to be ca. 316 and 827 mg/kg bw for female and male rats, respectively, resulting in an combined LD50 value of 527 mg/kg bw.

Acute inhalation toxicity

Five Wistar rats per sex were exposed in a study performed according to OECD 403 study to 2.2 mg/L air dust aerosol of the substance (BASF 1988). After an observation period of 14 days surviving animals were necropsied. Several clinical signs were observed during and after exposure, but all surviving animals were without symptoms after the 13th observation day.Only 1 animal died after exposure.The LC50 was determined to be >2.2 mg/L air.


Justification for selection of acute toxicity – oral endpoint
One acute oral toxicity study is available. This study is adequate for covering this endpoint.

Justification for selection of acute toxicity – inhalation endpoint
One acute inhalation toxicity study is available. This study is adequate for covering this endpoint.

Justification for classification or non-classification

Based on oral LD50 in rats of 527 mg/kg bw, (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride 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). Based on inhalation LC50 of > 2.2 mg/L air classification for acute inhalation is not warranted in accordance with EU Directive 67/548 (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.