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Toxicological information

Skin sensitisation

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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 black
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.