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

Endpoint summary

Description of key information

Skin irrittaion: Under the conditions of this study, the test material was determined to be not irritating to the skin of rabbits.

Eye irritation: Under the conditions of the study, the test material was found to be irritating to the eye of the rabbit.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

In the key study, the skin irritation potential of the test material was investigated in accordance with the standardised guidelines OECD 404 and EU Method B.4 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The undiluted test material was applied to the skin of three New Zealand White rabbits in a semi-occlusive fashion for 4 hours. At the end of the 4 hour exposure period, the test material was removed with Lutrol and Lutrol/water (1:1). Animals were observed 30 to 60 minutes after removal of the patches and after 24, 48 and 72 hours after the beginning of the application and scored for erythema and oedema formation.

An erythema score of 1 was obtained for one of the rabbits at the 24 hour observation. All other scores for erythema and all oedema scores were 0 at each time point.

Under the conditions of this study, the test material was determined to be not irritating to the skin of rabbits.

A supporting test was conducted to investigate the potential of the test material to cause irritation the skin of the rabbit. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The skin irritation test included topical application of the material to intact and abraded skin on the abdomen of a male New Zealand White rabbit. The two sites, which received either one (abraded site) or four (intact site) daily 0.5 mL applications, were subsequently wrapped with a flannel bandage. An unwrapped, intact site, located on the medial surface of the left ear pinna, received four daily 0.1 mL applications. The animal was on study for seven days.

Prolonged contact with the test material on the abraded sites resulted in very slight erythema and very slight oedema. No irritation was observed on the intact sites. Repeated contact on both intact sites resulted in essentially no irritation.

Repeated contact on the abraded site resulted in slight erythema, very slight oedema, and very slight exfoliation. Blisters were also observed on the abraded site.

It is not possible to classify the test material in accordance with EU criteria due to the lack of numerical scores for erythema and oedema at specified time points; however, the results on intact skin would imply that the test material is not irritating.

Eye Irritation

A study was conducted to investigate the potential of the test material to cause eye irritation in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

The right eye of each of three Vienna White rabbits was treated with a single 0.1 mL dose of test material in the conjunctival sac. The left eye of the rabbits was left untreated and served as a negative control. One rabbit was dosed initially and observed for a period of 15 days. Two further rabbits were then dosed and observed for a period of 21 days. The treated eyes were assed for corneal opacity, redness of the conjunctivae, chemosis, effects on the iris and discharge after 1, 24, 48 and 72 hours, then after 8 and 15 days. A final observation took place after 21 days for the second and third animals treated.

Effects were seen on all three eyes for all parameters investigated. In the first treated animal, all signs had reversed after 15 days. Animals 2 and 3 both still showed effects after 21 days, with the corneal scores for animal number 3 being at the highest possible value at the 15 and 21 days observation points.

Under the conditions of the study, the test material was found to be irritating to the eye of the rabbit, with the effects not being fully reversible within 21 days.

In a supporting study, the potential of the test material to cause irritation to the eye was investigated in the rabbit. The study was awarded a reliability score of 4 in accordance with the criteria set forth by Klimisch et al. (1997).

The eye irritation test included instillation of an aliquot of 0.1 mL of the test material into each conjunctival sac of a male New Zealand White rabbit. Topical anaesthetic was administered to alleviate discomfort experienced by the rabbit.

The single exposure resulted in moderate discomfort, moderate conjunctival redness and swelling, marked reddening of the iris and moderate corneal injury. All corneal effects were absent 7 days after exposure. All other effects were absent either 7 or 14 days after treatment.

It is not possible to classify the test material in accordance with EU criteria due to the lack of numerical scores for the different effects at specified time points; however, the results imply that the test material is irritating.

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 requires classification with respect to the eye as Category 1 (H318; Causes serious eye damage).