Reaction mass of 2-(3-ethylphenyl)oxirane and 2,2’-(1,3-phenylene)dioxirane and 2,2'-(1,4-phenylene)dioxirane

Endpoint summary

Description of key information

The test material was considered to be Irritant according to the EU labelling regulations during the dermal irritation study. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required. 
The test material did not meet the criteria for classification as an irritant (to the eye) according to the EU labelling regulations. No symbol or risk phrases are required.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritancy/Corrosion:

A study was performed to assess the skin irritation potential of the test material using the EPISKIN^TMreconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay.

The test material was considered to be Irritant. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.

A study was performed to assess the corrosivity potential of the test material using the EPISKIN^TMin vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).

The test material was considered to be Non-Corrosive to the skin.

A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man. 

0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32 °C ± 1.5 °C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9 % Sodium Chloride).

Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

The in vivo skin irritation study was waived since the submission substance had already been classified as an irritant in the in vitro skin irritation study using the EPISKINTM reconstituted Human Epidermis Model.

Eye Irritation

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted)Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008 and Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008.

A single application of the test material to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. One treated eye appeared normal at the 7-Day observation and the remaining treated eye appeared normal at the 14-Day observation.

The test material produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.

A study was performed to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man. 

0.1 ml of the test material was applied onto the cornea of each of three enucleated eyes which had been maintained at a temperature of 32°C ± 1.5°C within the superfusion chamber. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).

Following assessment of the data for all endpoints the test material was considered unlikely to have the potential to cause severe ocular irritancy in vivo.

Effects on skin irritation/corrosion: irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The test material was considered to be Irritant according to the EU labelling regulations during the dermal irritation study. The symbol “I” and the risk phrase R 38 “IRRITATING TO SKIN” are therefore required.

The test material did not meet the criteria for classification as an irritant to the eye according to the EU labelling regulations. No symbol or risk phrases are required.