Talc (Mg3H2(SiO3)4)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: gene mutation

Remarks:

Type of genotoxicity: gene mutation

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:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)

Principles of method if other than guideline:

rat dominant lethal assay.

GLP compliance:

yes

Type of assay:

rodent dominant lethal assay

Test material

Test material information

Constituent 1

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Groups of 10 male Sprague-Dawley rats
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 25 °C
- Humidity (%): 40 to 50 %
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

no

Details on exposure:

Groups of 10 male rats were dosed by gavage with a single dose or once daily for 5 days with 30, 300, 3000, or 5000 mg/kg talc. Saline was used as the negative controls and 0.1 μg/ml TEM (i.p.) was the positive control.

Duration of treatment / exposure:

once daily for 5 days

Frequency of treatment:

once a day

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

30 mg/kg bw/day

Doses / concentrations 2

Dose / conc.:

300 mg/kg bw/day

Doses / concentrations 3

Dose / conc.:

3 000 mg/kg bw/day

Doses / concentrations 4

Dose / conc.:

5 000 mg/kg bw/day

No. of animals per sex per dose:

10/male/dose

Control animals:

yes, concurrent vehicle

Positive control(s):

0.1 μg/ml TEM (i.p.) was the positive control.

Examinations

Tissues and cell types examined:

chromosome aberrations in the bone marrow or no dominant lethal mutations

Evaluation criteria:

Saline was used as the negative controls and 0.1 μg/ml TEM (i.p.) was the positive control.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

There were no dose-response or time trend patterns; talc did not induce dominant lethal mutations in this assay.

Additional information on results:

There were no dose-response or time trend patterns; talc did not induce dominant lethal mutations in this assay.

Applicant's summary and conclusion

Conclusions:

Interpretation of results : negative
In rats, no chromosome aberrations in the bone marrow or no dominant lethal mutations were observed after one or five administrations of 30 to 5000 mg talc/kg body weight

Executive summary:

Talc was not genotoxic in a rat dominant lethal assay.

Groups of 10 male rats were dosed by gavage with a single dose or once daily for 5 days with 30, 300, 3000, or 5000 mg/kg talc. Saline was used as the negative controls and 0.1 μg/ml TEM (i.p.) was the positive control.

There were no dose-response or time trend patterns; talc did not induce dominant lethal mutations in this assay.