Activated Carbon - High Density Skeleton

Endpoint summary

Description of key information

- Acute Dermal Irritation/Corrosion:
In vivo skin irritation test (OECD 404): not irritating.
- Acute Eye Irritation / Corrosion:
In vivo eye irritation test (OECD 405): not irritating.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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:

Perfomed under GLP, reliability score 2 because of missing substance identity information

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:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0392

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0392

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0393

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0393

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0394

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0394

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0395

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0395

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Reversibility:

other: Not relevant

Remarks on result:

other: Study report 0396

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hrs

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:

GHS criteria not met

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 criteria outlined in Annex I of 1272/2008/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 1272/2008/EC.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 April 2010 - 09 May 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Performed under GLP

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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 - 18 weeks
- Weight at study initiation: 2420 – 2584 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

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:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal # 1, 2 and 3

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Remarks:

animal # 1, 2 and 3

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.67

Max. score:

2

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 1

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 2

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal # 3

Time point:

other: 24, 48 and 72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The instillation of Steam 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, the end of the observation period for all animals. 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 clinical signs were observed.

Other effects:

No intercurrent deaths occurred during the course of the study. 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 at the 1-hour reading (in one animal) or from the 1-hour to the 48-hour reading (2 animals).

Interpretation of results:

GHS criteria not met

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 Annex I of 1272/2008/EC (CLP/EU-GHS), Steam 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 Steam Activated Carbon was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 g into the left eye of each of 3 young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours 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 0.67, 0.67 and 0.67 for reddening and 0.33, 0.00 and 0.33 for chemosis. The instillation of Steam 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, the end of the observation period for all animals. 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 Annex I of 1272/2008/EC (CLP/EU-GHS), Steam Activated Carbon does not have to be classified and has no obligatory labelling requirement with respect to eye irritation in rabbits.

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 showed no erythema or oedema effects after the application of Activated Carbon - High Density Skeleton (AC-HDS) 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.

In the key in vivo study available for eye irritation AC-HDS 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 AC-HDS.

Justification for classification or non-classification

Both key in vivo studies indicate that Activated Carbon - High 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) .