Registration Dossier

Administrative data

Description of key information

The registered substance 2-amino-4-hydroxyethylaminoanisole sulfate was evaluated on two tests by two different routes of exposure : one oral and one dermal, for potential subchronic toxicity (OECD Guideline 408 90 Days oral method, GLP compliant, Klimisch 1) (OECD Guideline 410 28 days dermal method, GLP compliant, Klimisch 1). The No Observed Adverse Level (NOAEL) was defined as 300 mg/kg/day for dermal route and as 15 mg/kg/day for oral route (gavage).

According to results of the key studies, a 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day. It is readily absorbed from the gastro-intestinal tract. Considering the effects observed at 50 and 200 mg/kg bw/day: anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, and according to CLP criteria the substanec should be classified as STOT RE Categoy 2, H373: May cause damage to organs (blood, thyroid, kidneys, pituitary) through prolonged or repeated exposure by oral route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
15 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
300 mg/kg bw/day
Study duration:
subacute
Species:
guinea pig

Additional information

Justification for classification or non-classification

A Repeated Dose (28 days) study in guinea pigs gave no indication of systemic toxic effects up to the maximum technically achievable dose of 300 mg/kg bw/day.