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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2011 – January 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2010
GLP compliance:
yes
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Carbon black
EC Number:
215-609-9
EC Name:
Carbon black
Cas Number:
1333-86-4
Molecular formula:
C
IUPAC Name:
carbon
Test material form:
solid: nanoform, no surface treatment

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female
Details on test animals and environmental conditions:
nulliparous, non-pregnant, 11 – 12 weeks old

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Concentration:
0, 0.25, 0.5, 1.0, 2.5, or 5.0%
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
Slight erythematic response at the site of application was seen in positive control animals. SI value for positive control animals was 3.52%

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
1.13
Test group / Remarks:
0.25% (w/v)
Remarks on result:
other: No treatment-related systemic clinical signs were observed
Key result
Parameter:
SI
Value:
1.2
Test group / Remarks:
0.5 % (w/v)
Remarks on result:
other: No treatment-related systemic clinical signs were observed
Key result
Parameter:
SI
Value:
1.23
Test group / Remarks:
1.0 % (w/v)
Remarks on result:
other: No treatment-related systemic clinical signs were observed
Key result
Parameter:
SI
Value:
1.26
Test group / Remarks:
2.5 % (w/v)
Remarks on result:
other: No treatment-related systemic clinical signs were observed
Key result
Parameter:
SI
Value:
1.24
Test group / Remarks:
5.0 % (w/v)
Remarks on result:
other:
Remarks:
No treatment-related systemic clinical signs were observed
Cellular proliferation data / Observations:
No significant increase in ear thickness in treated animals in comparison to vehicle and positive control groups.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acceptance criteria for the study was met i.e. 70% cell viabiity in negative control group and the SI for the positive control was greater than 3. SI value for the treated groups showed a less than 3 fold increase compared to negative control animals, hence, under experimental conditions, carbon black is not considered a contact sensitizer in the LLNA.