Registration Dossier

Administrative data

Description of key information

The substance was not irritating to skin and eyes in rabbits and the substance was not irritating to the respiratory system in rats. 

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 adverse effect observed (not irritating)

Additional information

Skin irritating properties of potassium tetrafluoroborate were studied in a GLP-compliant OECD Guideline 404 study with rabbits (Safepharm Laboratories Limited, 1992b). 0.5 g of the test substance moistened with 0.5 mL distilled water were applied under semi-occlusive conditions to the skin of 3 rabbits for 4 hours. After the removal of the patches animals were observed for 72 hours. No evidence of skin irritation was noted (erythema and edema scores were 0 at all time points (24, 48 and 72 hours) in all animals). Based on the results of the study, potassium tetrafluoroborate is considered to be not irritating to skin.

Eye irritating properties of potassium tetrafluoroborate were studied in a GLP-compliant OECD Guideline 405 study with rabbits (Safepharm Laboratories Limited, 1992c). 0.1 mL of the test material (ca. 99 mg) was instilled in one eye of three rabbits and the eyes were observed after 1, 24, 48 and 72 hours. Untreated eyes served as negative control. Residual test material was noted around the treated eye of two animals one hour after treatment. No corneal or iridial effects were noted during the study. Chemosis was noted in all treated eyes one hour after treatment (score 1). Minimal conjunctival redness persisted in one treated eye at the 24-hour observation (score 1; mean score at 24 + 48 + 72 hours for three animals 0.11). Treated eyes appeared normal 24-48 hours after treatment. Based on the results of the study, potassium tetrafluoroborate was concluded to be not irritating to eyes.

In the GLP-compliant 28 -day repeated dose inhalation toxicity study, performed according to OECD Guideline 407, no signs of respiratory irritation (clinical observations & histopathology) were observed at concentrations up to 225mg/m3.

Justification for classification or non-classification

Based on the results of the skin and eye irritation study, and the 28 -day repeated dose inhalation toxicity study, the substance does not need to be classified for skin, eye, and respiratory irritation according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.