Registration Dossier

Diss Factsheets

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

Referenceopen allclose all

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

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 
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

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 
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

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.

Mean in vitro Score: Negative control: 1.27; Positive control: 151.82; Test Substance: 21.57

Negative and positive controls were within historical ranges.

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.

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

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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) .