Registration Dossier

Administrative data

Description of key information

Reliable animal data were found indicating that lead oxide, lead phosphite and dibasic lead phthalate lack irritating properties for the skin or the eyes.

Sparingly soluble lead compounds do not exhibit irritant or corrosive properties in acute inhalation studies. There are no reports of respiratory irritation in occupationally exposed workers.

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

Reliable animal data were found indicating that lead oxide, lead phosphite and dibasic lead phthalate lack irritating properties for the skin or the eyes. The experimental data are reinforced by a lack of reports of skin or eye irritation in the many occupational exposure environments which provide opportunities for exposure of lead and sparingly soluble lead compounds to the skin and eyes. Classification for these endpoints is clearly not needed. Specific studies of lung irritation were not found, but the lack of inhalation toxicity from lead oxide in both acute toxicity testing and inhalation cancer bioassays combine with an absence of reports of lung irritation in occupational settings to suggest classification is not needed.

The substances for which data are available should permit data waiving for a number of other substances. The three tested compounds are all sparingly soluble (and thus unlikely to undergo significant dissolution when applied to the skin, eyes or inhaled. The tested compounds further include one compound with an organic anion and one with an inorganic anion. Literature searches have failed to identify anions in other sparingly soluble substances that would alter the irritant properties of other sparingly soluble lead salts. Finally, dermal, oral and inhalation toxicity studies for lead compounds are uniformly negative and further support a finding of no irritant properties. Data waiving for all irritant classification endpoints should thus be possible for metallic lead and other sparingly soluble lead salts (unless anions are present that literature searches suggest might impart irritating properties.

No studies were found documenting corrosive properties of lead and sparingly soluble lead compounds in either experimental animals or humans. Given the negative findings of acute toxicity and irritation studies and the absence of reports from occupationally exposed workers, corrosive properties are not to be expected of lead or its sparingly soluble compounds.


Justification for selection of skin irritation / corrosion endpoint:
Well-documented and corresponded to the requirements of the recommended Annex V test guidelines

Justification for selection of eye irritation endpoint:
Well-documented and corresponded to the requirements of the recommended Annex V test guidelines

Justification for classification or non-classification

No skin or eye irritation observed in experimental studies conducted according to Annex V test guidelines.

No evidence of respiratory irritation in rat acute toxicity studies up to 5mg/L and no reports of respiratory irritaion following extensive use of this substance in the workplace.