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Administrative data

Description of key information

Not irritating in a skin irritation assay in rabbits (BASF AG, 1968). 
Mild eye irritation in a eye irritation study in rabbits (BASF AG, 1968).
No indications for respiratory irritation in acute inhalation study including histopathology of respiratory tract (BASF AG, 2010).

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

Skin irritation

In a skin irritation assay with rabbits 1ml test substance was applied for exposure periods of 1, 5, 15 minutes and 20 hours under occlusive test conditions (BASF AG, 1968). Even under these very harsh exposure conditions, no skin irritation was observed.

 

Eye irritation

In a eye irritation study 0.05 ml of the test substance were applied to the conjunctival sac of one eye of two rabbits. The observation period comprised only 6 days and no rinsing was performed. Mild redness of conjunctivae, chemosis, corneal opacity and mucosal bleeding were observed (BASF AG, 1968). All observations were fully reversible within the 6 day observation period.

 

Respiratory tract irritation

In a recent OECD 403 acute inhalation guideline study neither mortality nor significant signs of systemic toxicity were observed in rats head/nose exposed for 4h to vapors at the limit dose of 20.8 mg/l (BASF AG, 2010). In the same study potential morphological changes in the respiratory tract were evaluated in a satellite group (3 male rats) exposed to the test substance simultaneously with the main group animals and sacrificed on post exposure study day 2. No indications for a respiratory irritation were identified.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

No classification for skin irritation is indicated according to EU regulations (GHS/DSD).

With respect to eye irritation no classification is indicated according to Dir 67/548/EEG. Though according to Regulation 1272/2008/EG, classification as an eye irritant Cat.2 (irritating to the eye) is indicated due to reversible median conjunctivae and cornea scores of 1.5.

Furthermore, based on the available data, no classification for respiratory irritation is indicated.