(1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride

Endpoint summary

Description of key information

Only standard information required at REACH Annex VIII is available for assessing the toxicokinetics for the test substance. The available test data do not permit conclusions concerning absorption, metabolism or excretion to be drawn conclusively. The test substance data requires that the test substance be classified for acute toxicity effects via the oral and inhalation routes and the effects observed in these studies and in the repeated dose and developmental screening test indicate that absorption and distribution of the test material in vivo is likely to occur. 

Key value for chemical safety assessment

Bioaccumulation potential:

low bioaccumulation potential

Additional information

The available test data do not permit conclusions concerning absorption, metabolism or excretion to be drawn. In the acute oral study, high mortality was observed at 300 and 2000 mg/kg with no mortality observed at 50 mg/kg (although adverse clinical signs were noted at this dose). In the acute inhalation study, at ca. 7 mg/L high mortality was observed with no mortality observed at ca. 1 mg/L.

In the combined repeated dose and developmental screening assay (OECD 422 study), there was no test substance related mortality, but findings included clinical signs, lower motor activity in conjunction with low bodyweight gain and food consumption. These findings were observed at all doses on study (although to a less significant degree at the lower dose). The clinical signs observed were reversible after a period post dosing.

These study findings potentially indicate that the test substance is absorbed via oral and inhalation exposure and distributed systemically. The reversibility of clinical signs seen in the repeated dose study indicates that the test substance could be rapidly eliminated by normal metabolic and excretory mechanisms.

No reproductive toxicity was observed at any dose tested indicating either low absorption to the relevant tissues involved or low general tissue toxicity. With regards to developmental effects, mean pup bodyweight at 25 and 50 mg/kg was reduced compared with controls, and given the magnitude of the lower pup bodyweight gain was considered to be adverse. This finding is most likely attributed to parental toxicity, as the lowest mean pup body weight gain per litter was noted for dams that showed weight loss during lactation. On Day 1 of lactation there were also no statistically significant differences in pup bodyweights at all doses compared with controls.

The substance was determined to be a skin sensitiser based on the results of a LLNA, indicating that the test substance potentially has the ability to pass through the dermal layers of the skin, and can induce proliferation of lymphocytes in the relevant draining lymph nodes.

There were no positive findings in any of the in vitro genotoxicity assays conducted.