Talc (Mg3H2(SiO3)4)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

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:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

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:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS (The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act of Animal Welfare the animals were bred for experimental purposes.)
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: Animals no. 1 - 3, step 1: 151 - 158 g; Animals no. 4 - 6, step 2: 161 -170 g
- Fasting period before study: Prior to administration food was withhel from the test animals for 16 to 19 hours (access to water was permitted). Food was provided again approximately 3 -4 hours post dosing.
- Housing: full-barrier in an air-conditioned room; The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 06.06.09)
- Diet: Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1452)
- Water: Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, multicipal residue control, microbiological control at regular intervals.)
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Relative humidity: 55 +/- 10%
- Air changes: 10x / hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Details on oral exposure:

A single oral dose of 5000 mg/kg of talc prepared as an 18.3% (w/v) suspension in saline was administered to 10 male rats.
The dose formulations were made shortly before each dosing occasion.
No further information on the oral exposure was stated.

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

10 male rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: All animals were observed for 14 days after dosing for general clinical signs morbidity and mortality.
- Frequency of observations and weighing: Prior to the administration a detailed clinical observation was made of all animals. Following the period of fasting the animals were weighed and the test item was administered.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also, respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: Yes
All animals were subjected to gross necropsy. All gross pathological changes were recorded.
No further information on the study design was stated.

Statistics:

No data

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: No signs of toxicity were observed in any of the animals.

Gross pathology:

No special gross pathological changes were recorded for any animal.

Other findings:

No data

Any other information on results incl. tables

Absolute Body Weights in g and Body Weight Gain in %

Animal no. / sex	g Day 1	g Day 8	g Day 15	% Day 1-15
Step 1 (5000 mg/kg bw)
1 / male	158	182	192	+22
2 / male	155	176	187	+21
3 / male	151	165	171	+13
Step 2 (5000 mg/kg bw)
4 / male	170	203	215	+26
5 / male	161	182	199	+24
6 / male	162	194	204	+26

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, a single oral application of the test item Talc (Mg3H2(SiO3)4) to rats at a dose of 5000 mg/kg body weight was associated with no signs of toxicity or mortality.
A single oral dose of 5000 mg/kg of talc prepared as an 18.3% (w/v) suspension in saline was administered to 10 male rats. All animals survived, and there were no signs of toxicity.
The median lethal dose of Talc (Mg3H2(SiO3)4) after a single oral administration to male rats, observed over a period of 14 days is :LD50 >5000 mg/kg body weight.

Executive summary:

Throughout the 14-day observation period, all animals survived until the end of the study without showing any signs of toxicity.

A single oral dose of 5000 mg/kg of talc prepared as an 18.3% (w/v) suspension in saline was administered to 10 male rats. All animals survived, and there were no signs of toxicity. In conclusion, the median lethal dose of Talc (Mg3H2(SiO3)4) after a single oral administration to male rats, observed over a period of 14 days is :LD50 >5000 mg/kg body weight