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

Endpoint summary

Description of key information

Acute oral toxicity: Under the conditions of this study, the LD50 was greater than 2200 mg/kg body weight (males and females).

Acute dermal toxicity: Under the conditions of this study, the LD50 was greater than 2000 mg/kg body weight (males and females).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 200 mg/kg bw

Quality of whole database:

Two studies are available. The key study was performed in accordance with standardised guidelines and under GLP conditions and was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be good.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Two studies are available. The key study was performed in accordance with standardised guidelines and under GLP conditions and was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The quality of the database is therefore considered to be good.

Additional information

Acute Oral Toxicity

The key study was conducted to investigate the acute oral toxicity of the test material in accordance with the standardised guidelines OECD 401 and EU Method B.1 under GLP conditions.

A group of ten fasted animals (five males and five females) was given a single oral dose of the test material prepared in olive oil DAB 9 at a dose level of 2200 mg/kg of bodyweight by gavage. Over a 14 day observation period, the animals were monitored for mortality, signs of toxicity and body weight gain. At the end of the observation period animals were sacrificed and subjected to necropsy with gross pathological examination.

No mortality occurred and no signs of toxicity were noted at this dose level. The expected body weight gains were observed throughout the course of the study. No abnormalities were noted at necropsy.

Under the conditions of this study, the LD50 was greater than 2200 mg/kg body weight (males and females).

In the supporting study, the potential of the test material to cause acute toxicity via the oral route was investigated in a limit test conducted using the rat. The study was awarded a reliability score of 4 in accordance with the criteria set forth by Klimisch et al. (1997).

Three male Fischer 344 rats received 2000 mg/kg of the undiluted test material by single dose oral gavage. Animals were monitored for body weight gain, in-life signs of toxicity and mortality for 14 days. At the end of the test, animals were subjected to necropsy.

No in-life signs of toxicity were observed in the rats. All rats survived and eventually gained body weight during the two week observation period. All tissues were within normal limits at necropsy.

Under the conditions of this study, the acute oral LD50 for male Fischer 344 rats was greater than 2000 mg/kg.

Acute Dermal Toxicity

The key study was conducted to investigate the acute dermal toxicity of the test material in accordance with the standardised guidelines OECD 402 and EU Method B.3 under GLP conditions.

The undiluted test material ground down to a fine dust was prepared on a compress moistened with water at a limit dose of 2000 mg/kg and then applied to the skin of 10 Sprague-Dawley rats (5 males and 5 females). The material remained on the skin for 24 hours under a semi-occlusive dressing.

Over a 14 day observation period, the animals were monitored for mortality, signs of toxicity and body weight gain. At the end of the observation period animals were sacrificed and subjected to necropsy.

The general behaviour and body weight gain of the animals were not affected by treatment. No deaths occurred at 2000 mg/kg. Macroscopic examination at the end of the study revealed no abnormalities.

Under the conditions of this study, the LD50 was greater than 2000 mg/kg body weight (males and females).

In the supporting study, the potential of the test material to cause acute toxicity via the dermal route was investigated in a limit test conducted using the rabbit. The study was awarded a reliability score of 4 in accordance with the criteria set forth by Klimisch et al. (1997).

Two female New Zealand White rabbits received a single 24 hour dermal application of 2000 mg/kg of the undiluted test material. Animals were monitored for body weight gain, in-life signs of toxicity and mortality for 14 days. At the end of the test, animals were subjected to necropsy.

No in-life signs of toxicity were observed in the rabbits. Dermal effects on the application sites included erythema, oedema, and, on one rabbit, a scab. All rabbits survived and gained body weight during the two week observation period. At necropsy, a scab was observed on the application site of one rabbit. Mucus, which was present in the colon of the same rabbit, was considered an incidental finding and not related to treatment. All other tissues were within normal limits.

Under the conditions of this study, the acute dermal LD50 for female New Zealand White rabbits was greater than 2000 mg/kg.

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 acute toxicity via the oral and dermal routes.