Silicon carbide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

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)

Details on test animals or test system and environmental conditions:

Body weight of animals at the commencement of the study: female 204 – 221 g and male 243 – 251 g.
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 five days)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

The test item was applied as a single dose, uniformly over an area which was approx. 10% of the total body surface.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure, residual test item was removed by using tap water.

Duration of treatment / exposure:

24 hours

Observation period:

Animals were observed for 14 days after dosing.

Number of animals:

10 (5 female and 5 male animals were used)

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin changes at the application sites were observed throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an acute dermal toxicity test with silicon carbide (crude and grains) no skin changes at the application sites of the test animals were observed throughout the observation period. From this it can be concluded that the substance is not a skin irritant.

In an acute dermal toxicity test with silicon carbide (crude and grains) no skin changes at the application sites of the test animals were observed throughout the observation period. From this it can be concluded that the substance is not skin corrosive.

In addition, documented occupational experience with the handling and use of silicon carbide (crude and grains) has revealed no cases of eye or dermal corrosion (i.e. irreversible damage to the skin or to the eye).