Pivaloyl chloride

Endpoint summary

Description of key information

Pivanoyl chloride causes burns on the skin. This implies the possible risk of severe eye damage, which was found in one of the two relevant studies.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

skin:

Undiluted PCl (0.5 mL) was applied to the clipped intact skin of New Zealand White rabbits (3/sex) under semi-occlusive conditions for 4 hours (Stillmeadow, 1986d). Erythema and oedema were present at each observation time through Day 21 (PDII = 7.0/8.0), indicating the substance is severely irritating to skin. Since necrosis was present on the test sites of all 6 animals, the substance is considered to be corrosive to skin.

 

eye:

In an eye irritation study, 0.1 mL undiluted PCl was placed into the conjunctival sac of the right eye of each of 9 rabbits (strain not specified) (Stillmeadow, 1986). The lids were held together for one second. Three of the nine treated eyes were each washed with water for 1 minute, 30 seconds after treatment. The untreated left eye served as a control. PCl was moderately irritating (maximum average score of 39.8 in nonwashed eyes was obtained at 24 hours; the score for washed eyes at this time was 33.3) in this test. Positive staining(with 0.2% fluorescein sodium ophthalmic solution)occurred in all nonwashed eyes and 2 washed eyes at 24 hours. Staining resolved in nonwashed and washed eyes by Days 7 and 4, respectively. 

In a guideline study (similar to OECD TG 405), 0.05 mL of the PCl was applied into the conjunctival sac of one rabbit's eye (strain not specified) (BASF, 1969). Marked eye reactions were noted at one and 24 hours. Erythema and chemosis subsided, but corneal opacity persisted until the end of the observation period (day 8). Although this test did not use the required volume (0.1 mL) as outlined in the test guidelines, irreversible eye damage was noted with much less test material (0.05 ml), and the test was considered valid.

Justification for classification or non-classification

Based on the available data a classification concerning skin irritation (Skin corr/irr Cat 1B) is warranted according to regulation 1272/2008/EC causes severe burns on the skin. This impies the possible risk of severe eye damage.

Based on the skin corrosion and the inhalation toxicity of the substance the additional labeling with EUH071 (corrosive to the respiratory tract) is recommended.