Sulphuric acid, compound with graphite

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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.

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:

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:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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:

ECGA97914xH(21T9-2)

Test animals

Species:

rat

Strain:

other: WISTAR Crl: WI(Han) rats (Full-Barrier)

Sex:

male/female

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)

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

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

Details on dermal exposure:

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 ating tape and was fixed with an additional dressing in a suitable manner.

Duration of exposure:

24 hours

Doses:

The test item was applied at a single dose of 2000 mg/kg body weight to each animal.

No. of animals per sex per dose:

10 (5 female and 5 male animals were used)

Control animals:

no

Details on study design:

The test item was used without further treatment. In order to ensure good skin contact, it was slightly moistened with Aqua ad injectionem (B. Braun Melsungen, lot no. 7494A191).The animals were marked for individual identification by tail painting. Approximately 24.5 hours before the test, the fur from the male animals was removed from the dorsal area and approximately 24 hours before the test, the fur from the female animals was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. No less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals. Animals were observed for 14 days after dosing. The animals were weighed prior to application, once a week thereafter and at the end of the study. A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). Thereafter the animals were observed for clinical signs once daily until the end of the observation period. 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. At the end of the observation period the animals were sacrificed by an overdosage of pentobarbital injected intraperitoneally (Narcoren®, Merial; lot no.: 193089) at a dosage of approx. 8 mL/ kg body weight. All animals were subjected to gross necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality observed

Clinical signs:

other: The minor findings observed are considered to be not clearly treatment related.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were recorded for any animal.

Other findings:

Erythema grade 2 and a small wound close to the application site was observed in 1 of 5 male animals. The signs of irritation were reversible within the observation period.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, the single dermal application of the test item Expandable Natural Graphite to rats was not associated with relevant signs of toxicity and mortality and does not cause primary skin irritation.The dermal LD50 in rats was determined to be > 2000 mg/kg body weight.

Executive summary:

Under the conditions of the present study, the single dermal application of the test item Expandable Natural Graphite to rats was not associated with relevant signs of toxicity and mortality and does not cause primary skin irritation.

The dermal LD50 in rats was determined to be > 2000 mg/kg body weight.

In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Expandable Natural Graphite has no obligatory labelling requirement for toxicity. According to Annex I of Regulation (EC) 1272/2008 the test item Expandable Natural Graphite does not require classification for acute percutaneous toxicity since neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000 mg/kg body weight. According to OECD-GHS (Globally Harmonized Classification System) the test item Expandable Natural Graphite does not require classification for acute percutaneous toxicity since neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000 mg/kg body weight.