Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

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Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
a short-term toxicity study does not need to be conducted because a sub-chronic (90 days) or chronic toxicity study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration
Justification for type of information:
A 90 day repeat dose toxicity study by oral route is proposed for lithium 12-hydroxystearate.

The category members are almost exclusively produced and used directly in grease form. They have vapour pressures of less than 10 E-10 Pa and melting points of greater than 160°C, so the potential for the generation of inhalable forms is low, also the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Only two category substances (Fatty acids C16-18, lithium salts and Lithium 12-hydroxystearate) are produced to some extent in solid form and then subsequently formulated into grease by occupational downstream users. From the granulometry data on the solid, generation of dusts of an inhalable size cannot be excluded. General accepted OELs derived for inert (nuisance) dust/particulates not otherwise classified (PNOCs), of 10 mg/m³ for chronic and 20 mg/m³ for acute exposure to inhalable dust and of 3 mg/m³ for chronic and of 6 mg/m³ for acute exposure to alveolar (respirable) dust) are applicable and must be adhered to, to avoid non-specific inhalation dust toxicity. Thus, at the production, and occupational downstream users' sites, the exposure to dusts/aerosols can be assumed as insignificant due to personal protective and engineering RMMs routinely implemented to comply with the general dust OELs. Thus, by adherence to the general dust limits, the exposure and potential risk to humans can be considered to be sufficiently controlled.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion