Activated Carbon - Low Density Skeleton

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 April 2010 - 13 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

performed under GLP

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)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

2008

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Remarks:

Statement of Compliance

Test material

Test material information

Constituent 1

Reference substance name:

carbon

EC Number:

931-334-3

Molecular formula:

C

IUPAC Name:

carbon

Details on test material:

- Name of test material (as cited in study report): Chemically Activated Carbon
- Physical state: powder
- Analytical purity: confidential
- Lot/batch No.: confidential
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature (range of 20 ± 5 °C, light protected

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands
- Age at study initiation: 16 - 17 weeks
- Weight at study initiation: 2500 – 2942 g
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls.
- Diet: Pelleted standard Kliba Nafag 3418 rodent maintenance diet available ad libitum.
- Water: Community tap water from Füllinsdorf ad libitum
- Acclimation period: 5-6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g/animal
- Concentration (if solution): undiluted (100%)

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

1, 24, 48, and 72 hours, and at 7 days after treatment

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: The eye reactions were assessed according to the numerical scoring system listed in the Commission Regulation (EC) No 440/2008, B.5, at approximately 1, 24, 48, 72 hours after administration. Scleral reddening and ocular discharge were also assessed.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, 4153 Reinach / Switzerland)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal # 1, 2 and 3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal # 1, 2 and 3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal # 3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 3

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The instillation of Chemically Activated Carbon into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis of the conjunctivae and ocular discharge. These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed.

Other effects:

No intercurrent deaths occurred during the course of the study. One animal slighly lost body weight during acclimatization. However, the animal regained weight during the treatment, indicating a normal health status. Otherwise, the body weight of the animals was within the range commonly recorded for this strain and age. Black test item remnants were observed in the treated eyes of all animals from the 1-hour reading to the 72-hour reading.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

based on CLP criteria

Conclusions:

The test item did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in 1272/2008/EC (CLP/EU-GHS), Chemically Activated Carbon does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.

Executive summary:

The primary eye irritation potential of Chemically Activated Carbon was investigated according to OECD test guideline no. 405. The test item was applied by instillation into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7 days after test item instillation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.67 and 0.67 for reddening and 0.00, 0.00 and 0.33 for chemosis. The instillation of Chemically Activated Carbon into the eye resulted in mild, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, chemosis of the conjunctivae and ocular discharge. These effects were reversible and were no longer evident 72 hours after treatment. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no clinical signs were observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based on these results and according to the EU criteria outlined in 1272/2008/EC (CLP/EU-GHS), Chemically Activated Carbon does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.