Registration Dossier

Administrative data

Description of key information

SKIN
Jacobs: Not irritating
Zissu: Not irritating
EYE
Jacobs: not irritating

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 adverse effect observed (not irritating)

Additional information

Two studies to standard protocols in rabbits showed no sign of irritation to the skin in any of the animals used. In a separate study using the Draize protocol slight irritancy was seen, with a primary irritation index of 1.3. Overall, the data suggests negligible skin irritation potential.

A standard protocol study assessed the eye irritancy potential of 2 -methoxyethanol in rabbits. Even without a washing stage, the substance showed negligible iritis or corneal effects. Very mild chemosis was seen and slight to moderate conjunctivitis. Both of the latter were still present at the end of the 4 day experiment but were showing signs of recovery suggesting that they would have vanished within the normal 21 day observation period. Those lesions that were seen had either disappeared or were showing signs of recovery by the end of the 4 day study. The conclusion was that the initial lesions were of a mild nature and did not meet the criteria for classification as an eye irritant. No other reliable eye irritancy studies to standard protocols are available, although a study which looked at tissue swelling as a surrogate for irritancy found no physiological effects for a single exposure to a 25% methoxyethanol solution in water. A case history of human eye exposure to 2 -methoxyethanol showed that prompt healing occured within 48 hours, suggesting that human eye irritancy potential is low.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

2 -methoxyethanol shows no irritating potential to skin.

2 -methoxyethanol shows slight irritating potential to eyes but the severity of the acute lesions seen are well below the thresholds that would require classification as an eye irritant under EU criteria. The data available suggests that lesion reversal occurs within a reasonable timeframe.

There is no data that suggest classification for respiratory irritancy is required.