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Registration Dossier
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EC number: 931-334-3 | CAS number: -
- 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

Endpoint summary
Administrative data
Description of key information
- Acute Dermal Irritation/Corrosion (read-across from Activated Carbon - High Density Carbon):
In vivo skin irritation test (OECD 404): not irritating.
- Acute Eye Irritation / Corrosion:
In vitro eye irritation test - Bovine Corneal Opacity and Permeability test (BCOP test) (OECD 437, September, 2009): mild eye irritant.
In vivo eye irritation test (OECD 405): not irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 April 1988 - 22 April 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted according to OECD Guideline 404 and under GLP conditions. As the substance identity is not clear the study and due to the read-across purpose (in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID), the study was assigned a Klimisch 2 rating.
- Justification for type of information:
- Read across from activated carbon HDS was applied. The justification for read across is attached as a separate document to the "Toxicological information" summary
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approx. 3 months
- Weight at study initiation:
Study report 0392: 2.58-2.87 kg
Study report 0393: 2.78-3.00 kg
Study report 0394: 2.60-3.17 kg
Study report 0395: 2.54-3.14 kg
Study report 0396: 2.98-3.07 kg
- Housing: Individually
- Diet (e.g. ad libitum): Ad libitum, standard pelleted rabbit diet
- Water (e.g. ad libitum): Ad libitum, tap water
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (15-23)
- Humidity (%): 55 (40-70)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Other flank of animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days (1 hour, 24, 48 and 72 hours after removal of dressing)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsum, moistened with 0.2 ml of water before application
- % coverage: No data (3x2 cm)
- Type of wrap if used: Unmedicated gauze patch, held in place by strips of Blenderm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Where necessary, the treatment sites were gently washed with warm water and dried with paper towels to remove excessive amounts of test material adhering to the skin
- Time after start of exposure: Diretly after removal of dressing
SCORING SYSTEM:
Erythema and eschar formation:
0 - No erythema
1 - Very slight erythema (barely perceptible)
2 - Well-defined erythema
3 - Moderate to severe erythema
4 - Severe erythema (beet redness) to slight eschar formation (injury in depth)
Oedema formation:
0 - No oedema
1 - Very slight oedema (barely perceptible)
2 - Slight oedema (edges of area well-defined by definite raising)
3 - Moderate oedema (raised approx. 1 mm)
4 - Severe oedema (raised more than 1 mm and extending beyond the area of exposure) - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0392
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0392
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0393
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0393
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0394
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0394
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0395
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0395
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0396
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0396
- Irritant / corrosive response data:
- Grey discolouration of test sites of animals was observed in 4/5 studies, but this was not considered to be caused by an irritating potential of activated carbon. In most individual cases this effect was reversible within 72 hours. All control sites failed to show any response to the control procedure.
- Other effects:
- Not relevant
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The studies assessed the irritating potential of Activated carbon in rabbits (OECD 404 test). No erythema or oedema effects were observed, indicating that Activated carbon can be considered as a non-irritant to skin under the conditions of the tests. This was based on the EU criteria outlined in Annex I of 1272/20008/EC.
- Executive summary:
The skin irritating potential of Activated carbon was assessed in multiple studies (5 samples of Activated carbon) in rabbits (OECD 404). Animals were exposed for 4 hours and observed thereafter for 72 hours (at 1, 24, 48 and 72 hours after removal of test substance). Three rabbits were used per study, every animal was its own control (other flank of the animal).
The studies showed no erythema or oedema effects after the application of Activated carbon within 72 hours. In 4/5 studies grey discolouration of the treated skin was seen. In most individual cases this effect was reversible within 72 hours.
Therefore, the test substance does not need to be classified as skin irritant according to the the EU
criteria outlined in Annex I of 1272/20008/EC
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read across from activated carbon HDS was applied. The justification for read across is attached
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0392
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0392
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0393
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0393
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0394
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0394
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0395
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0395
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0396
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not relevant
- Remarks on result:
- other: Study report 0396
- Irritant / corrosive response data:
- Grey discolouration of test sites of animals was observed in 4/5 studies, but this was not considered to be caused by an irritating potential of activated carbon. In most individual cases this effect was reversible within 72 hours. All control sites failed to show any response to the control procedure.
- Other effects:
- Not relevant
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- The skin irritating potential of AC-HDS was assessed, and the results are used for Read across to AC-LDS. The studies assessed the irritating potential of Activated carbon in rabbits (OECD 404 test). No erythema or oedema effects were observed, indicating that Activated carbon can be considered as a non-irritant to skin under the conditions of the tests. This was based on the EU criteria outlined in Annex I of 1272/20008/EC.
- Executive summary:
The skin irritating potential of AC-HDS was assessed, and the results are used for Read across to AC-LDS. The skin irritating potential was assessed in multiple studies (5 samples of Activated carbon) in rabbits (OECD 404). Animals were exposed for 4 hours and observed thereafter for 72 hours (at 1, 24, 48 and 72 hours after removal of test substance). Three rabbits were used per study, every animal was its own control (other flank of the animal).
The studies showed no erythema or oedema effects after the application of Activated carbon within 72 hours. In 4/5 studies grey discolouration of the treated skin was seen. In most individual cases this effect was reversible within 72 hours.
Therefore, the test and target substance do not need to be classified as skin irritant according to the the EU
criteria outlined in Annex I of 1272/20008/EC
Referenceopen allclose all
Study report | Endpoint | Irritation scores at timepoints of evaluation | |||
1 | 24 | 48 | 72 | ||
0392 | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0393 | Erythema | 0* | 0* | 0* | 0* |
Oedema | 0 | 0 | 0 | 0 | |
0394 | Erythema | 0* | 0* | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0395 | Erythema | 0* | 0* | 0* | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0396 | Erythema | 0* | 0* | 0* | 0* |
Oedema | 0 | 0 | 0 | 0 | |
*Grey discolouration |
Study report | Endpoint | Irritation scores at timepoints of evaluation | |||
1 | 24 | 48 | 72 | ||
0392 | Erythema | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0393 | Erythema | 0* | 0* | 0* | 0* |
Oedema | 0 | 0 | 0 | 0 | |
0394 | Erythema | 0* | 0* | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0395 | Erythema | 0* | 0* | 0* | 0 |
Oedema | 0 | 0 | 0 | 0 | |
0396 | Erythema | 0* | 0* | 0* | 0* |
Oedema | 0 | 0 | 0 | 0 | |
*Grey discolouration |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- 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
- 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 - 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) - 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 22, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline for Testing of Chemicals 437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants (September, 2009).
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: INVITTOX (UK) protocol no. 98 "The Bovine Corneal Opacity and Permeability Assay", February 1994.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997.
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: not relevant: in vitro test
- Strain:
- other: Bovine
- Details on test animals or tissues and environmental conditions:
- BOVINE EYES
- Source: Odenwaldschlachthof Brensbach, 64395 Brensbach, Germany
- Age at study initiation: animals were at least nine month old - Vehicle:
- physiological saline
- Remarks:
- 20% (w/v)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml
VEHICLE
- Concentration (if solution): 20% (w/v)
POSITIVE CONTROL: 10% (w/v) Benzalconium chloride in 0.9% (w/v) NaCl - Duration of treatment / exposure:
- 240 minutes (± 5 minutes)
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- 9 freshly isolated bovine cornea: negative control, positive control and test item: 3 cornea each.
- Details on study design:
- EXPOSURE OF THE CORNEA: in cornea holder (closed chamber)
INCUBATION: 1 hour
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item or control items, respectively, were rinsed off from the application side by changing cMEM (complete Minimum Essential Medium), three times.
- Time after start of exposure: 240 minutes
SCORING SYSTEM: (See also: Other information on materials and methods)
The following formula was used to determine the in vitro score of the negative control:
In vitro Score = opacity value + (15 x OD490 value)
The following formula was used to determine the in vitro score of the positive control and the test item:
In vitro Score = (opacity value - opacity value mean negative control) + (15 x corrected OD490 value)
The in vitro score was calculated for each individual treatment and positive control cornea. The mean in vitro score value of each treated group was calculated from the individual in vitro score values.
TOOL USED TO ASSESS SCORE:
Cornea opacity value: opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom France)
Permeability (optical density value) at 490 nm (OD490): fluorescein; spectrophotometer. - Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 1, difference t240-t0 opacity
- Value:
- ca. 19.67
- Remarks on result:
- other: corrected value
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 2, difference t240-t0 opacity
- Value:
- ca. 19.67
- Remarks on result:
- other: corrected value
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 3, difference t240-t0, opacity
- Value:
- ca. 23.67
- Remarks on result:
- other: corrected value
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 1, permeability at 490 nm (OD490)
- Value:
- ca. -0.015
- Remarks on result:
- other: corrected value
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 2, permeability at 490 nm (OD490)
- Value:
- ca. -0.015
- Remarks on result:
- other: corrected value
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- cornea 3, permeability at 490 nm (OD490)
- Value:
- ca. 0.142
- Remarks on result:
- other: corrected value
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea 1
- Value:
- ca. 19.45
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea 2
- Value:
- ca. 19.45
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- cornea 3
- Value:
- ca. 25.8
- Irritation parameter:
- other: mean in vitro score
- Run / experiment:
- mean cornea 1,2 and 3
- Value:
- ca. 21.57
- Irritant / corrosive response data:
- The test item, Chemically activated carbon, did not cause any relevant permeability of the corneae, but slight opacity effects occurred compared with the results of the negative control. This effect is probably caused by the fact, that it was not possible to wash the black test item off the corneae completely.
- Interpretation of results:
- other: Mild eye irritant
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- In this Bovine Corneal Opacity and PermeabilityAssay (BCOP) assay the calculated mean in vitro score was 21.57 and therefore, the test item was classified as mild eye irritant.
- Executive summary:
This in vitro study was performed according to OECD Guideline 437 to assess the corneal irritation and damage potential of Chemically activated carbon by means of the Bovine Corneal Opacity and Permeability Assay (BCOP) using fresh bovine corneae. After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item Chemically activated carbon, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 2 ºC in complete medium. After the incubation phase, the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240).
After the opacity measurements, permeability of the corneae was determined while application of 1 ml of a fluorescein solution for about 90 minutes at 32 ± 2 ºC in a horizontal position. The liquid coming out was measured spectrophotometrically.
With the negative control (0.9% NaCl solution) neither an increase of opacity nor permeability of the corneae could be observed. The mean in vitro score was calculated as 1.27. The positive control (10% (w/v) Benzalconium chloride) showed clear opacity and distinctive permeability of the corneae and therefore, is classified as very severe eye irritant. The mean in vitro score was calculated as 151.82.
The test item, Chemically activated carbon, did not cause any relevant permeability of the corneae, but slight opacity effects occurred compared with the results of the negative control. This effect is probably caused by the fact, that it was not possible to wash the black test item off the corneae completely. The calculated mean in vitro score was 21.57 and therefore, the test item was classified as mild eye irritant.
Referenceopen allclose all
Mean in vitro Score: Negative control: 1.27; Positive control: 151.82; Test Substance: 21.57
Negative and positive controls were within historical ranges.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The multiple studies for assessing the skin irritating potential (read-across from Activated Carbon - High Density Skeleton) showed no erythema or oedema effects after the application of Activated carbon within 72 hours. In 4/5 studies grey discolouration of the treated skin was seen. In most individual cases this effect was reversible within 72 hours. Therefore, the test substance is considered to be non-irritant.
The key studies available for eye irritation were:
- An in vitro eye irritation test (BCOP test). Activated Carbon - High Density Skeleton, did not cause any relevant permeability of the corneae, but slight opacity effects occurred compared with the results of the negative control. This effect is probably caused by the fact, that it was not possible to wash the black test item off the corneae completely. The calculated mean in vitro score was 21.57 and therefore, the test item was classified as mild eye irritant.
- An in vivo eye irritation test did not induce any significant or irreversible damage to the rabbit eye. It is concluded that the test substance is a non irritant.
The respiratory irritation was not studied for Activated Carbon - Low Density Skeleton
.
Justification for classification or non-classification
The irritating effect in the in vitro eye irritation test (BCOP test) is probably caused by the fact, that it was not possible to wash the black test item off the corneae completely. Both in vivo key studies indicate that Activated Carbon - Low Density Skeleton does not induce any significant irritation to the skin and eye. Therefore, it can be concluded that the substance is not irritating and therefore does not need to be classified as such according to the criteria outlined in Annex I of 1272/2008/EC (CLP/EU-GHS) .
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