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EC number: 235-819-4 | CAS number: 12777-87-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 December 2009 - 28 April 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, L 142, Annex Part B
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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:
- EECGA97914xH(21T9-2)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White Rabbits Crl: KBL (NZW)
- Details on test animals or tissues and environmental conditions:
- 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.Body weight at the beginning of the study: > 2kgAge at the beginning of the study: approximately 25 weeks oldThe animals were barrier maintained (semi-barrier) in an air conditioned room- Temperature: 18 ± 3 °C (recommendations of TVT, GV-SOLAS)- Relative humidity: 55 ± 10 %- Artificial light, sequence being 12 hours light, 12 hours dark- Air change: at least 10 x / hour- Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0748), rich in crude fibre- Free access to tap water (drinking water, municipal residue control, microbiolog. controlled periodically)- Certificates of food, water and bedding are filed at BSL Bioservice- Housed in ABS - plastic rabbit cages, floor 4200 cm2- Adequate acclimatisation period (at least 5 days)
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- The animals were observed for 72 hours after dosing. To determine the reversibility of the observed effects, the observation period was extended up to 10 days after dosing.
- Number of animals or in vitro replicates:
- Number of animals: 3 (females)
- Details on study design:
- Approximately 24 hours before the test and immediately prior to the application both eyes of each animal were examined. A health inspection was performed to ensure the good state of health of the animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- cornea opacity
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0.34
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days post instillation
- Irritation parameter:
- conjunctivae score
- Remarks:
- conjunctival redness
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days post instillation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days post instillation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Conjunctival redness
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 10 days post instillation
- Irritation parameter:
- chemosis score
- Remarks:
- Conjunctival chemosis
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days post instillation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Conjunctival redness
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1.34
- Max. score:
- 2
- Reversibility:
- fully reversible within: 6 days post instillation
- Irritation parameter:
- chemosis score
- Remarks:
- Conjunctival chemosis
- Basis:
- animal #3
- Time point:
- other: (24, 48, 72 hour reading
- Score:
- 1.34
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days post instillation
- Irritant / corrosive response data:
- The test item produced irritant, but no corrosive ocular effects after instillation into the eyes of 3 female rabbits
- Other effects:
- Upon fluorescein examinations at the end of the observation period of 72 h as well as at the end of the prolonged observation period no corneal lesions were found in any animal. Conjunctival discharge grades 1 and 2 was observed in all three animals.Conjunctival redness and chemosis were also observed in animals no. 1, 2 and 3, and are individually described in Tables no. 3, 4 and 5.
Any other information on results incl. tables
The test item produced irritant, but no corrosive ocular effects after instillation into the eyes of 3 female rabbits (strain NZW)
Neither mortalities nor significant clinical signs of toxicity were observed.
The eyes were rinsed with physiological saline NaCl 0.9%.
Upon fluorescein examinations at the end of the observation period of 72 h as well as at the end of the prolonged observation period no corneal lesions were found in any animal.
Conjunctival discharge grades 1 and 2 was observed in all three animals.
There were no significant body weight changes during observation period
Conjunctival redness and chemosis were also observed in animals no. 1, 2 and 3.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, single ocular instillation of the test item Expandable Natural Graphite to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 7 days in animal no. 1, within 10 days in animal no. 2 and within 6 days in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.
- Executive summary:
Under the conditions of the present study, single ocular instillation of the test item Expandable Natural Graphite to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 7 days in animal no. 1, within 10 days in animal no. 2 and within 6 days in animal no. 3. Neither mortalities nor significant clinical signs of toxicity were observed.
In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC and Annex I of Regulation (EC) 1272/2008, the test item Expandable Natural Graphite does not have to be classified and has no labelling requirement for eye irritation.
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