Registration Dossier
Registration Dossier
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EC number: 205-154-4 | CAS number: 134-72-5
Endpoint summary
Administrative data
Description of key information
In an acute oral toxicity study the LD50 was determined to be 189 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 189 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
Five Wistar rats per sex per dose were exposed, in a acute oral toxicity study similar to OECD guideline 401, to 68.1, 100, 147.0, 215, 316, and 464 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. Several clinical signs were observed such as dyspnea, apathy, excitation, abnormal position, staggering, tremors, twitching, tonus of the jaws, tonic convulsions, piloerection, exophthalmos, salivation, imbalance, and a poor general state. These effects were absent after 2 days. Upon necropsy edematous lungs and focal hyperemia were observed in animals that died. The LD50 was determined to be 189 and more than 464 mg/kg bw for females en males, respectively.
In the second study (NTP 1986, rats) Fischer 344/N rats were exposed to 75, 150, 300, 600, and 1200 mg/kg bw. Hyperkinesia that progressed to convulsive seizure, ataxia, and lethargy were observed in animals that died. Pathology showed mild portal-hepatic congestion, mild pulmonary congestion, and epistaxis. The LD50 was determined to be between 75 and 150 mg/kg bw. In the third study (NTP 1986, mice) B6C3F1 mice were exposed to 125, 250, 500, 1000, 2000 mg/kg bw. Hyperkinesia that progressed to convulsive seizure, ataxia, and lethargy were observed in animals that died. Pathology showed mild portal-hepatic congestion, mild pulmonary congestion, and epistaxis. The LD50 was determined to be 812 and 1072 mg/kg bw for males and females, respectively.
Justification for selection of acute toxicity – oral endpoint
Three acute oral toxicity studies are available, performed in two species. The study was chosen in which the most sensitive species was used (rat) and surviving animals were necropsied at the end of the study.
Justification for classification or non-classification
Based on an oral LD50 of 189 mg/kg bw bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate has to be classified for Acute toxicity Cat 3: H301: Toxic if swallowed in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and T: R25: Toxic if swallowed in accordance with Directive 67/548/EEC (DSD).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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