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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 November 2007 - 29 February 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OPPTS 870.1000 (Acute toxicity testing background)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

1
Chemical structure
Reference substance name:
Silicon carbide
EC Number:
206-991-8
EC Name:
Silicon carbide
Cas Number:
409-21-2
Molecular formula:
SiC
IUPAC Name:
methyl-λ¹-silanylidyne

Test animals

Species:
rat
Strain:
other: HsdRccHan: WIST rats (Full-Barrier)
Sex:
female
Details on test animals or test system and environmental conditions:
Step 1: Body weight at the commencement of the study: 169 – 200 g;
Step 2: Body weight at the commencement of the study: 175 – 186 g.
The age of the animals at the time of delivery was 7-8 weeks. The age of the animals at the start of the study was 8-9 weeks.
The animals were derived from a controlled full barrier maintained breeding system (SPF).
The animals were barrier maintained (semi-barrier) in an air conditioned room
- Temperature: 22 +/- 3 °C
- Rel. humidity: 55 +/- 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- The animals were kept in Macrolon cages on Altromin saw fiber bedding
- Certificates of food, water and bedding are filed at BSL Bioservice
- Adequate acclimatization period (at least 5 days)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test item was administered in a single dose by gavage using an intubation cannula, at a volume of 10 mL/kg body weight.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 (3 animals were used for each step)
Control animals:
no

Results and discussion

Effect levels
Dose descriptor:
other: NOAEL
Effect level:
2 000 mg/kg bw
Mortality:
no deaths
Clinical signs:
other: No treatment related effect was observed.
Gross pathology:
Beside acute injection of blood vessels in the abdominal region, w hich is due to the euthanasia injection, no specific gross pathological changes were found in any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this toxicity test it can be stated that the test item showed no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test item w as classifiedin to Category 5 (LD50 cut-off: unclassified).
Executive summary:

According to an acute oral toxicity test conducted with silicon carbide (crude and grains) it can be stated that the substances shows no orally toxic characteristics. The oral LD50in rats was determined to be > 2000 mg/kg body weight.