Sulphuric acid, compound with graphite

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 December 2009 - 17 February 2010

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:

2010

Report date:

2010

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: EC 440/2008

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

Constituent 1

Reference substance name:

Sulphuric acid, compound with graphite

EC Number:

235-819-4

EC Name:

Sulphuric acid, compound with graphite

Cas Number:

12777-87-6

Molecular formula:

Cm+ HSO4-* n H2SO4

IUPAC Name:

sulphuric acid, compound with graphite

Details on test material:

Expandable Natural Graphite

Test animals

Species:

rat

Strain:

other: WISTAR Crl: WI(Han) rats (full barrier)

Details on test animals or test system and environmental conditions:

Body weight of test animals at the beginning of the study: females: 205 - 233 g, males: 251 - 286 gThe animals were derived from a controlled full barrier maintained breeding system (SFP).The animals were barrier maintained (Full-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- Free access to Altromin 1324 maintenance diet for rats and mice- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiol. controlled periodically)- The animals were kept individiually in IVC cages, type III H, polysulphone cages on Altromin sawfiber bedding- Certificates of food, water and bedding are filed at BSL Bioservice- Adequate acclimatisation period (at least 5 days)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipping

Vehicle:

other: Aqua ad injectionem (B. Braun melsungen, lot no. 7494A191)

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:

erythema score

Basis:

animal #4

Remarks:

male rat

Time point:

other: during entire observation period

Score:

2

Max. score:

4

Reversibility:

fully reversible within: the observation period

Irritant / corrosive response data:

Signs of erythema was assessed on one female rat during entire observation period.

Other effects:

A small wound close to the application site was observed (day 2 - day 12) on the animal which showed erythemal effects. A further male rat showed slight bloody secretion at the penis on day 2 of 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 Expandable Natural Graphite minor skin changes at the application sites of only one test animal was observed throughout the observation period. Despite this observation it can be stated that the substance is primary not a skin irritant.

In an acute dermal toxicity test with Expandable Natural Graphite no observations regarding skin corrosive effects have been conducted.

In addition, documented occupational experience with the handling and use of sulphuric acid, compound with graphite has revealed only minor dermal irritation (i.e. irreversible damage to the skin) in one case but no dermal corrosion during up to 20 years of manufacture, handling and use.