Sulphuric acid, compound with graphite

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:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Test guideline 3

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

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:

EECGA97914xH(21T9-2)

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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.