Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Cross-reference
Reason / purpose:
reference to other study

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:

Exposure to rock wool fibers produced no interstitial fibrosis or neoplastic lesions at any time point.
Rock wool (stone wool) produced no fibrotic response or neoplasms.
These studies demonstrate that the inhalation of high levels of rock (stone) and slag wools, while causing nonspecific inflammatory lesions (rock and slag wool) and fibrosis with high lung burden of long fibers (rock wool only) in the lungs of exposed rats, showed no evidence of carcinogenic activity. These results suggest that respirable fractions of these MMVFs should not pose a significant health risk to humans at the relatively low airborne levels found in the workplace.
So are assessed to be not mutagenic.
Executive summary:

Long term inhalation studies prove that:

Exposure to rock wool fibers produced no interstitial fibrosis or neoplastic lesions at any time point.

Rock wool (stone wool) produced no fibrotic response or neoplasms.

These studies demonstrate that the inhalation of high levels of rock (stone) and slag wools, while causing nonspecific inflammatory lesions (rock and slag wool) and fibrosis with high lung burden of long fibers (rock wool only) in the lungs of exposed rats, showed no evidence of carcinogenic activity. These results suggest that respirable fractions of these MMVFs should not pose a significant health risk to humans at the relatively low airborne levels found in the workplace.

So are assessed to be not mutagenic.