Registration Dossier

Administrative data

Description of key information

An eye irritation study according to OECD guidelines and GLP principles is available. A skin irritation study with exposure during 24h under occlusion on intact and abraded skin is available. Both showed that the substance is not irritating for skin and eye.

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

Skin

In an in vivo skin irritation study, rabbits were exposed to 0.5 g of 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2 –ol on intact or abraded skin for 24 h under occlusion. Some slight irritation due to effects on erythema is observed directly after exposure. This effect was decreased after 48 hours, mean score of 1. Therefore, it was concluded that the substance does not have to be classified for skin irritation.

Eye

An in vivo eye irritation study is performed according to OECD, EC, EPA and JMAFF test guidelines. Instillation of approximately 48 mg of 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2 –ol (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in redness of the conjunctivae. The irritation had completely resolved within 24 hours in two animals and within 48 hours in the other animal. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. Therefore, the substance is considered to be not irritating to the eyes.

Justification for classification or non-classification

Based on these results 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2 –ol does not have to be classified and has no obligatory labelling requirement for eye irritation according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Based on the observed slight irritation of exposed abraded skin after 24h of exposure, which effect was decreased after another 48h (mean score is 1 at 72h ), 1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2 –ol does not have to be classified and has no obligatory labelling requirement for dermal irritation according to the:

- Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2007),

- Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.