Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
To induce skin sensitisation, the target substance must be bioavailable in the skin (i.e. it must penetrate the stratum corneum of the skin), therefore skin penetration is a prerequisite for the induction of skin sensitisation (step 1 in the Adverse Outcome Pathway for skin sensitisation, OECD 2012). However, nanomaterials usually do not penetrate the skin, recently summarised e.g. in a publication written by the ECETOC Nano Task Force (Landsiedel et al., 2017). In line with that, in vivo skin sensitisation studies with other carbon-based NM do not indicate a skin sensitisation potential of carbon-based NM: multiwalled carbon nanotubes (MWCNT) were found negative in guinea pigs (OECD TG 406, Ema et al., 2011 and Murthy et al., 2011 - see cross-reference for supporting information); singlewalled carbon nanotubes (SWCNT) were also negative in guinea pigs (OECD TG 406, Ema et a., 2011). Indeed, a recent review on the immunomodulatory effects of nanomaterials upon skin exposure summarised the currently available data on related skin sensitisation testing, which do not indicate any relevant skin sensitisation potential (Yoshioka et al. 2017).
In addition, in case of considerable skin penetration, compounds must also generate an antigen to be presented to T cells by antigen-presenting cells such as dendritic cells. However, graphene oxide was found to suppress antigen presentation by dendritic cells in vitro (Tkach et al. 2013), indicating a rather immunosuppressive capacity under certain conditions.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no details given
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Remarks:
- GLP compliance is not specified in this publication
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- no details given
- Specific details on test material used for the study:
- MWCNT1: 5-8 microns in length with 3-8 nm inside diameter and outside diameter of 140 ± 30 nm; Product No. 659258 purchased from Sigma-Aldrich, USA.
The multi-walled carbon nanotubes used in the study were produced by catalytic chemical vapor deposition (CCVD). MWCNT1 were composed of 99.9 % carbon with small amount (<0.1% Fe) of iron. The manufacturer specification for nanomaterial characterization was confirmed by the following techniques. MWCNT1 characteristics were assessed in the as-synthesized form prior to use for experiments or after dispersion in the vehicle (distilled water) for dosing. Solution characteristics were measured with dynamic light scattering (DLS). - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 400 g
- Housing: individually in standard stainless steel cages and sterilized paddy husk as bedding. Bedding material was changed daily, whereas water bottles were changed on alternate days
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet food (supplier: M/s. Amrut Laboratory Animal Feed, Pune). The diet was supplemented with ascorbic acid.
- Water (e.g. ad libitum): ad libitum supply of UV treated water. The food and water was routinely analyzed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ±20 %
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- purified
- Concentration / amount:
- 400 mg
- Day(s)/duration:
- induction (day 1), same treatment was repeated on days 7 and 14
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 200 mg
- Day(s)/duration:
- challenge on day 28, observation 30 and 54 h after challenge
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- - Exposure period: day 0, day 7, day 14
- Test groups: 20 animals
- Control group: 10 animals
- Site: One flank of each animal was closely clipped free of hair, without any abrasion, 24 hours before the induction exposure
- Frequency of applications: 3 times
- Duration: 6h
- Concentrations: 400 mg
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Test groups: 20 animals
- Control group: 10 animals
- Site: posterior flank of both treatment and control groups
- Concentrations: 200 mg
- Evaluation (hr after challenge): 30h and 54 h after application challenge - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None of the animals treated with MWCNT1 showed any dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None of the animals treated with MWCNT1 showed any dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Conclusions:
- None of the animals treated with MWCNT1 exhibited any dermal reactions. Hence MWCNT1 can be considered as non-sensitizer.
- Executive summary:
In order to assess the skin sensitisation potential of MWCNT1, the Buehler Test was performed in 30 (20 test and 10 control) male Dunkin Hartley guinea pigs in accordance with OECD 406 and the Directive 96/54/EEC, B.6.
The test substance at a dose of 400 mg was applied to all animals of the treatment group for a period of 6 h. The same treatment was repeated on days 7 and 14. Similarly, the animals in the control group were treated with distilled water. On day 28, 200 mg of the test material was applied via a cotton pad to both treatment and control groups for 6 h.
The skin reactions were observed and scored at 30 h and 54 h after application. None of the animals treated with MWCNT1 exhibited any dermal reactions, hence MWCNT1 can be considered as non-sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- no details given
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Remarks:
- GLP compliance is not specified in this publication
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- no details given
- Specific details on test material used for the study:
- MWCNT 2: 1-10 microns in length with 2-6 nm inside diameter and outside diameter of 10-15 nm; Product No. 677248, purchased from Sigma-Aldrich, USA.
The multi-walled carbon nanotubes2 used in the study were produced by catalytic chemical vapor deposition (CCVD). The MWCNT2 were composed of 99.9 % carbon with small amount (<0.1% Fe) of iron. The manufacturer specification for nanomaterial characterization was confirmed by the following techniques. MWCNT2 characteristics were assessed in the as-synthesized form prior to use for experiments or after dispersion in the vehicle (distilled water) for dosing. Solution characteristics were measured with dynamic light scattering (DLS). - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation:
300 - 400 g
- Housing:
individually in standard stainless steel cages and sterilized paddy husk as bedding. Bedding material was changed daily, whereas water bottles were changed on alternate days
- Diet (e.g. ad libitum):
ad libitum standard rabbit pellet food (supplier: M/s. Amrut Laboratory Animal Feed, Pune). The diet was supplemented with ascorbic acid.
- Water (e.g. ad libitum):
ad libitum supply of UV treated water
The food and water was routinely analyzed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
- Acclimation period:
5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
20 ± 3 °C
- Humidity (%):
50 ±20 %
- Photoperiod (hrs dark / hrs light):
12 h light/dark cycle - Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Remarks:
- purified
- Concentration / amount:
- 400 mg
- Day(s)/duration:
- induction (day 1), same treatment was repeated on days 7 and 14
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 200 mg
- Day(s)/duration:
- challenge on day 28, observation 30 and 54 h after challenge
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 (test group)
10 (control group) - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures:
- Exposure period: day 0, day 7, day 14
- Test groups: 20 animals
- Control group: 10 animals
- Site: One flank of each animal was closely clipped free of hair, without any abrasion, 24 hours before the induction exposure
- Frequency of applications: 3 times
- Duration: 6h
- Concentrations: 400 mg
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28
- Test groups: 20 animals
- Control group: 10 animals
- Site: posterior flank of both treatment and control groups
- Concentrations: 200 mg
- Evaluation (hr after challenge): 30h and 54 h after application challenge - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None of the animals treated with MWCNT2 showed any dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None of the animals treated with MWCNT2 showed any dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Conclusions:
- None of the animals treated with MWCNT2 exhibited any dermal reactions. Hence MWCNT2 can be considered as non-sensitizer.
- Executive summary:
In order to assess the skin sensitisation potential of MWCNT2, the Buehler Test was performed in 30 (20 test and 10 control) male Dunkin Hartley guinea pigs in accordance with OECD 406 and the Directive 96/54/EEC, B.6.
The test substance at a dose of 400 mg was applied to all animals of the treatment group for a period of 6 h. The same treatment was repeated on days 7 and 14. Similarly, the animals in the control group were treated with distilled water. On day 28, 200 mg of the test material was applied via a cotton pad to both treatment and control groups for 6 h.
The skin reactions were observed and scored at 30 h and 54 h after application. None of the animals treated with MWCNT2 exhibited any dermal reactions, hence MWCNT2 can be considered as non-sensitizer.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, it is concluded that the substance does not need to be classified according to Regulation (EC) No 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
