Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Pyrochlore:

The overall chemical and physiological properties of pyrochlore are principally characterised by a degree of inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which the majority of atoms are tightly bound and not prone to dissolution in environmental and physiological media. This has been shown in in-vitro bioaccessibility testing for antimony, in which dissolved Sb concentrations were below 105µg/L even at the highest loading of 0.1g/L, thus implying a solubility of < 0.12% of antimony. Hence, Sb can be considered as not bioavailable and is not regarded concerning toxicological and environmental effects.

On the other hand, lead dissolution levels were much higher (up to 6.2 mg/L at pH 1.7) and therefore have to be regarded concerning toxicological and environmental aspects. No substance-specific data on the toxicity of pyrochlore are available, so that instead read-across to lead oxide and sparingly soluble lead compounds was conducted.

Lead:

Three studies according to OECD 406 with the substances dibasic lead phosphite, dibasic lead phthalate and LITHARGE lead oxide have been performed. Animal and human data specifically evaluating skin or lung sensitisation were not found. However, in view of the lack of toxicity, irritation or reports of sensitisation from occupational exposure settings, lead and sparingly soluble lead compounds do not appear to pose risk of sensitisation and classification for these endpoints is not indicated.

Migrated from Short description of key information:
Based on the assumption that lead is the only significantly bioavailable from the pigment pyrochlore, all available data suggests this pigment does not have skin sensitisation potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Considering the absence of evidence of respiratory sensitization responses, this endpoint is not expected to be of concern for lead and lead compounds.


Migrated from Short description of key information:
While is no particular study addressing respiratory sensitisation in experimental animals, there is no information suggesting lead compounds to cause such effects in animals.Taking into account the complete absence of skin sensitization potential of lead compounds, respiratory sensitisation is not expected to be of concern for the lead compound considered in this chemical safety report.

Justification for classification or non-classification

Pyrochlore:

The overall chemical and physiological properties of pyrochlore are principally characterised by a degree of inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which the majority of atoms are tightly bound and not prone to dissolution in environmental and physiological media. This has been shown in in-vitro bioaccessibility testing for antimony, in which dissolved Sb concentrations were below 105 ug/L even at the highest loading of 0.1g/L, thus implying a solubility of < 0.12% of antimony. Hence, Sb can be considered as not bioavailable and is not regarded concerning toxicological and environmental effects.

On the other hand, lead dissolution levels were much higher (up to 6.2 mg/L at pH 1.7) and therefore have to be regarded concerning toxicological and environmental aspects. No substance-specific data on the toxicity of pyrochlore are available, so that instead read-across to lead oxide and sparingly soluble lead compounds was conducted.

Lead:

According to the EEC Directive 2001/59/EEC, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 november 1999 (BGB1. I, p. 2233), the test article "ALLSTAB LP 3139 dibasic lead phosphite" can be classified as a "non-sensitiser since no allergic responses were observed in test animals after the adjuvant test according to Magnusson & Kligman.

According to the EEC Directive 2001/59/EEC, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233), thetest article PEBETAL dibasic lead phthalate can be classified as a "non-sensitiser" since no allergic responses were observed in test animals after the adjuvant test according to Magnusson & Kligman.

According to the EEC Directive 2001/59/EEC, 6 August 2001 and the Gefahrstoffverordnung (GefStoffV) of 15 November 1999 (BGB1. I, p. 2233) testconditions described, the test article "LITHARGE lead oxide" can be classified as a "non-sensitiser" since no allergic responses were observed in test animals under the experimental conditions described.

All sensitization test results were unequivocally negative and are considered to be representative of results to be expected for other sparingly soluble inorganic lead compounds.

Based upon the preceding observations, there is no indication that any of the sparingly soluble high production volume lead compounds (including lead metal) require classification for skin sensitisation.