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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Activated Carbon - High Density Skeleton
EC Number:
931-328-0
Molecular formula:
C
IUPAC Name:
Activated Carbon - High Density Skeleton
Details on test material:
- Name of test material (as cited in study report): Activated carbon (5 samples: A, B, C, D and Standard)
- Substance type: Black granular
- Physical state: Solid
- Storage condition of test material: At ambient temperature

Test animals

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

Test system

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)

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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 

Applicant's summary and conclusion

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