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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Some in vivo and in vitro studies carried out with talc samples.
Author:
Endo-Capron S, Fleury-Feith J, Nebut M, De Neef R, and Jaurand MC.
Year:
1990
Bibliographic source:
NATO ASI Series, Series G. 1990;21:(Health Related Effects of Phyllosilicates):369-375.

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
Principles of method if other than guideline:
primary screening by the chromosomal aberration test in vitro
GLP compliance:
not specified
Type of assay:
in vitro mammalian cell transformation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Talc (Mg3H2(SiO3)4)
EC Number:
238-877-9
EC Name:
Talc (Mg3H2(SiO3)4)
Cas Number:
14807-96-6
Molecular formula:
H2Mg3O12Si4
IUPAC Name:
Talc (Mg3H2(SiO3)4)
Test material form:
solid

Method

Target gene:
rat pleural mesothelial cells (RPMC).
Species / strain
Species / strain / cell type:
mammalian cell line, other: rat pleural mesothelial cells (RPMC)
Details on mammalian cell type (if applicable):
In the SCE assay, RPMC were treated with 0, 2, 5, 10, and 15 μg/cm2 of each talc sample for 48 h.
Additional strain / cell type characteristics:
not specified
Metabolic activation:
without
Test concentrations with justification for top dose:
Two negative reference particle controls, anatase and attapulgite, and the two positive controls reference particles named previously were used, as were the chemical controls mitomycin C in water and K2CrO4 in culture medium.
Vehicle / solvent:
chemical controls mitomycin C in water and K2CrO4 in culture medium.
Controls
Untreated negative controls:
yes
Remarks:
untreated cells
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Details on test system and experimental conditions:
In the SCE assay, RPMC were treated with 0, 2, 5, 10, and 15 μg/cm2 of each talc sample for 48 h. Two negative reference particle controls, anatase and attapulgite, and the two positive controls reference particles named previously were used, as were the chemical controls mitomycin C in water and K2CrO4 in culture medium.
Evaluation criteria:
Two negative reference particle controls, anatase and attapulgite, and the two positive controls reference particles named previously were used, as were the chemical controls mitomycin C in water and K2CrO4 in culture medium. T
Statistics:
no data

Results and discussion

Test results
Species / strain:
mammalian cell line, other: rat pleural mesothelial cells (RPMC)
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
Exposure of rat pleural mesothelioma cells to 3 talc samples and 3 asbestos fibre samples as a positive control (anatase, chrysotile and crocidolite) led to increased sister chromatid exchange and to increased DNA repair synthesis (UDS) only with the asbestos samples, but not with the talc samples
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

Talc did not cause a statistically significant increase in SCEs and was not clastogenic. The negative particle controls and chemical controls gave expected results; chrysotile and crocidolite statistically significantly increased SCEs in 2/4 and 3/8 experiments, respectively.
Executive summary:

The test substance is non-mutagenic under the given experimental conditions.