Registration Dossier

Administrative data

Description of key information

Based on the result of the key study (OCED 401 method equivalent, Klimish 2), the registered item 2-amino-4-hydroxyethylaminoanisole sulfate was defined as Toxic Acute Hazard Category 4 according to GHS regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
588 mg/kg bw
Quality of whole database:
LD50 calculated by the method of Spearman-Karber :
LD50 rat, female: 588 mg/kg bw
LD50 rat, male: 475 mg/kg bw
LD50 mouse, female: 538 mg/kg bw

Additional information

Three studies, quoted as Klimisch 2 were availables for the acute oral toxicity. They were all considered as key studies. The most relevant study was performed on rat. The two others were performed on mice.This relevant study (OECD Guideline method 401 comparable, non-GLP, Klimish 2) was performed to assess the acute oral toxicity of test item in rats by oral route.The animals received a single dose of test substance by gastric gavage at 5 dose levels ranging from 250 to 750 mg/kg bw in rats. They were observed daily for clinical signs and mortalities for 14 days. Bodyweights were recorded weekly and macroscopic abnormalities were recorded at autopsy. No histological examinations were performed.

At dosages of 375 mg/kg bw and above, deaths in rats occurred mainly after 4-5 days. Clinical signs noted were tonic spasm, piloerection, higher respiration rate in both rats and mice, but it was unclear if these

occurred at all doses. Surviving animals appeared normal thereafter. Weight gain was normal for the strain used. Autopsy of the animals surviving up to day 14 were reported to be normal

Based on the observed mortality, the following LD50 figures were calculated by the method of Spearman-Kärber:

LD50 rat, female: 588 mg/kg bw

LD50 rat, male: 475 mg/kg bw

Justification for classification or non-classification

The key study was not up to modern standards but the results give an indication of the LD50 in both rats after oral exposure (gavage). Based on this LD50 value, the registered item (2-amino-4 -hydroxyethylaminoanisole sulfate) was classified as Toxic Acute Hazard Category 4 according to CLP (LD50 in range of 300 mg/kg/day to 2000 mg/kg/day)