Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 December 2009 - 06 May 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 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:
other: Commission Regulation (EC) 440/2008, L142, Annex Part B
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OPTTS 870.1000 (Acute toxicity testing background)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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:
methane; sulfuric acid
Details on test material:
ECGA97914xH(21T9-2)

Test animals

Species:
rat
Strain:
other: WISTAR Crl: WI(Han) (Full-Barrier)
Sex:
female
Details on test animals or test system and environmental conditions:
Age at the beginning of the study: 9 - 10 weeks oldBody weight at the beginning of the study:Animals no. 1 – 3, step 1: 165 – 179 g; Animals no. 4 – 6, step 2: 177 – 204 g;The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.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 in groups in IVC cages, type III H, polysulphone cages on Altromin saw fiber bedding- Certificates of food, water and bedding are filed at BSL Bioservice- Adequate acclimatisation period (at least 5 days)The animals were marked for individual identification by tail painting.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Remarks:
Sigma, lot no. 038K0009, expiry date: 11/04/2010
Details on oral exposure:
The test item was administered at a single dose by gavage using a feeding tube, at a dose volume of 10 mL/kg body weight.
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
6 (3 animals for each step)
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
other: LD50 (cut off)
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No compound related mortality was recorded during the study period.
Clinical signs:
other: No signs of toxicity have been conducted during the whole observation period.
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:
At necropsy, no macroscopical findings were observed in any animal of any step.

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, single oral application of the test item Expandable Natural Graphite to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.The median lethal dose of Expandable Natural Graphite after single oral administration to female rats, observed over a period of 14 days is:LD50 cut off (rat): unclassifiedIn conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Expandable Natural Graphite has no labelling requirement for toxicity.According to Annex I of Regulation (EC) 1272/2008 the test item Expandable Natural Graphite was unclassified.According to OECD-GHS (Globally Harmonized Classification System) the test item Expandable Natural Graphite has no labelling requirement for toxicity.
Executive summary:

Two groups, each of three female WISTAR Crl: WI (Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in a vehicle (cottonseed oil) at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg.

All animals after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study without showing any signs of toxicity.

Throughout the 14-day observation period, the weight gain of the animals was within the expected range.

At necropsy, no macroscopical findings were observed in any animal of any step.

On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.