7
Respiratory or skin sensitization
No evidence from human epidemiological studies of any respiratory or skin sensitization potential.
Germ cell mutagenicity
genotoxicity
Method: In vitro micronucleus test
Species: Hamster (CHO)
Dose: 1-35 mg/ml
Routes of administration: In suspension
Results: Negative
Carcinogenicity
Method: Inhalation, multi-dose
Species: Rat
Dose: 3 mg/m
3
, 9 mg/m
3
and 16 mg/m
3
Routes of administration: Nose only inhalation
Results: Fibrosis just reached significant levels at 16 and 9 mg/m
3
but not at 3 mg/m
3
. None of the parenchymal
tumor incidences were higher than the historical control values for this strain of animal.
Method: Inhalation, single dose
Species: Rat
Dose: 30 mg/m3
Routes of administration: Nose only inhalation
Results: Rats were exposed to a single concentration of 200 WHO fibers/ml specially prepared RCF for 24
months. High incidence of exposure-related pulmonary neoplasms (bronchoalveolar adenomas and
carcinomas) was observed.
small number of mesotheliomas were observed in each of the fiber exposur
groups (Mast et al 1995a).
Method: Inhalation, single dose
Species: Hamster
Dose: 30 mg/m3
Routes of administration: Nose only inhalation
Results: Hamsters were exposed to a single concentration of 260 WHO fibers/ml specially prepared RCF for 18
months and developed lung fibrosis, a significant number of pleural mesotheliomas (42/102) but no primary lung
tumors (McConnell et al 1995).
Method: Inhalation, single dose
Species: Rat
Dose: RCF1: 130 F/ml and 50 mg/m3 (25% of non fibrous particles)
RCF1a: 125 F/ml and 26 mg/m3 (2% of non fibrous particles)
Routes of administration: Nose only inhalation
Results: Rats were exposed to RCF1 and RCF1a for 3 weeks. The objective of the study was to compare lung
retention and biological effects of the original RCF1 compared to RCF1a. The main difference of these 2
samples was the non-fibrous particle content of respectively 25% versus 2%. The post treatment observation
was 12 months.
lveolar clearance was barely retarded after RC
1
exposure.
fter RCF1 exposure,
however, a severe retardation of clearance was observed. (Bellmann et al 2001).
fter intraperitoneal injection of ceramic fibers into rats in three experiment
(Smith et al 1987, Pott et al 1987,
Davis et al 1984), mesotheliomas were found in the abdominal cavity in two studies, while the third repor
(Pott
et al 1987) had incomplete histopathology. Only a few mesotheliomas were found in the abdominal cavity of
hamsters after intraperitoneal injection in one experiment (Smith et al 1987). However, the ceramic fibers tested
were of relatively large diamete
. When rats and hamsters were exposed via intraperitoneal injection, tumor
incidence was related to fiber length and dose (Smith et al 1987, Pott et al 1987, Miller et al 1999, Pott et al
1989). (From SCOEL publication (EU Scientific Committee on Occupational Exposure Limits)
SCOEL/SUM/165, September 2011).
Reproductive toxicity
Method: Gavage
Species: Rat
Dose: 250mg/kg/day
Routes of administration: Oral
Series 31XX, 32XX Furnaces | Appendix A: SDS Information 31
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