Registration Dossier

Administrative data

Description of key information

Skin irritation:
rabbit, 4h, semiocclusive: not irritating (BASF 1986, OECD 404)
rabbit, 24h, occlusive: slightly irritating (BASF 1994, USA/EPA/FIFRA: Subdivision F, Series 81, GLP)
rabbit, 24h, occlusive: not irritating (BASF 1997, Federal Register 38, No 187, Paragraph 1500.41, GLP)
rabbit, 24h, occlusive: slightly irritating (BASF 1984, Federal Register 38, No 187, Paragraph 1500.41)
Eye irritation
rabbit: not irritating (BASF 1986, OECD 405)

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:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Several in vivo guideline studies exist, that evaluate the skin irritating potential of Oxirane, methyl-, polymer with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate. Only the first one was performed according to current OECD guideline 404 (BASF 1986). Intact skin of 1 male and 2 female White Vienna rabbits was exposed to 0.5ml of the test substance for four hours under semi-occlusive conditions. No erythema or edema were observed in any animal within the first 72 hours, and the study was terminated after 3 days.

In a study according to the USA/EPA/FIFRA guideline, subdivision F, Series 81 and GLP (BASF 1994), 6 New Zealand White rabbits were treated with 0.5ml of the test substance under occlusive conditions for 24 hours. Edema grade 1 was observed in one rabbit only. Erythema scores ranged from 0.5 to 3 (individual grades: 0.5, 1, 2.5, 2.5, 1.5, 3), half of which were not fully reversible within 72 hours.

In a similar study performed according to Federal Register 38, No 187, Paragraph 1500.41 and GLP (BASF 1997), also 6 New Zealand White rabbits were treated with 0.5ml of the test substance for 24 hours under occlusive conditions. In this case, no edema were observed, and only 2 out of 6 rabbits showed erythema grade 0.5 (mean value from 24h, 48h, and 72h reading).

6 White Vienna rabbits were exposed to 0.5 ml of the test substance for 24 hours using occlusive conditions in an additional study according to Federal Register 38, No 187, Paragraph 1500.41 and GLP (BASF 1984). All animals showed erythema between grade 1 and 2.6 (mean values from 24h, 48h, and 72h readings), and edema grade 0.3 (3 animals) or grade 2 (3 animals).

No eye irritation was observed in an in vivo study according to OECD 405 (BASF 1986). 0.1 ml of the test substance was applied to the eyes of 2 male and 1 female White Vienna rabbit. All scores for iris, cornea, chemosis and conjunctival redness were 0, except for one rabbit which showed a mean value (24 - 72h) of 0.3 for conjunctival redness.

Justification for classification or non-classification

Two of the four skin irritation studies, which were performed under harsh occlusive conditions, only showed a slight irritating potential, which was just not sufficient for classification according to 67/548/EEC and CLP/EU-GHS. Since the other two studies, of which one was performed according to current OECD recommended conditions, while the other also used long-term occlusive exposure, showed no skin irritation, no classification is warranted. In addition, no eye irritating potential was observed. Thus Oxirane, methyl-, polymer with oxirane, ether with 2 -ethyl-2 -(hydroxymethyl)-1,3 -propanediol (3:1), 2 -propenoate is not required to be classified for its skin or eye irritating properties according to 67/548/EEC and CLP/EU-GHS requirements.