Methyl (R)-2-(4-hydroxyphenoxy)propionate

Endpoint summary

Description of key information

Oral Route: Under the conditions of this study, the 28 day No Observable Adverse Effect Level was 1000 mg/kg/day (males and females).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

Only one study is available; it was conducted in accordance with standardised guidelines under GLP conditions and was assigned a reliability score of 1 in accordance with the criteria of Klimisch et al. (1997). The quality of the database is therefore considered to be good.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral Route

The potential for the test material to cause repeated dose toxicity was investigated in accordance with the standardised guidelines OECD 407 and EU Method B.7 under GLP conditions.

Four groups of 6 male and 6 female Sprague-Dawley rats received the test material daily by gavage for 4 weeks at doses of 0 (control), 15, 150 or 1000 mg/kg/day. The vehicle was aqueous methylcellulose at 1 %. The animals were checked at intervals each day for clinical signs and mortality. Food consumption was measured weekly during the treatment period and body weights were determined weekly from allocation to experimental groups throughout to termination. Haematological and blood biochemistry investigations were performed on day 28. On day 30, all the animals were sacrificed and a macroscopic examination performed. Designated organs were weighed and a range of tissues preserved for microscopic examination.

Ptyalism was observed from day 2 or 3 of treatment in all males and females given 1000 mg/kg/day. This clinical sign was considered to be treatment-related. No mortalities occurred during the course of the study. The food consumption and body weight gain of all treated groups was similar to that of respective controls during the study. There were no treatment related findings among the haematological parameters. A slightly lower plasma inorganic phosphorus concentration was observed in males given 1000 mg/kg/day, with a slightly higher plasma triglyceride concentration in males of the same group. These findings were considered to be treatment-related. There were no treatment-related effects on the weights of those organs determined. None of the macroscopic and microscopic findings noted were considered to be treatment-related.

The daily oral administration of the test material to rats for 4 weeks at doses of 15, 150 or 1000 mg/kg/day was well tolerated inducing at 1000 mg/kg/day only ptyalism and minor changes in plasma inorganic phosphorus and triglyceride concentrations. In isolation, these effects are of doubtful toxicological importance. The No Observable Effect Level is 150 mg/kg/day but the No Observable Adverse Effect Level of the test material is 1000 mg/kg/day.

Under the conditions of this study, the No Observable Adverse Effect Level was 1000 mg/kg/day (males and females).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to repeated dose toxicity via the oral route.