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Toxicological information

Dermal absorption

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Administrative data

Endpoint:
dermal absorption in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
September - December 2012
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature

Data source

Reference
Reference Type:
secondary source
Title:
Carbon Black - In Vitro Absorption of Carbon Particles through Dermatomed Human Skin - Visualisation of Carbon Particles Using Transmission Electron Microscopy
Author:
Johnson IR
Year:
2013
Bibliographic source:
as cited in: SCCS (Scientific Committee on Consumer Safety), Opinion on carbon black (nano-form), 12 December 2013, SCCS/1515/13, first revision of 27 March 2014, second revision of 15 December 2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 428 (Skin Absorption: In Vitro Method)
Version / remarks:
2004
GLP compliance:
yes

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
Specific details on test material used for the study:
Test Cosmetic Formulation: Black 2/CI 77266 12%, water 64.14%, gums 3.3%, propylene glycol 15%, trilaureth-4 phosphate 2%, preservatives 1.06%, alcohol denat 2.5%; primary particle size of carbon black: 20-30 nm
Radiolabelling:
no

Test animals

Species:
human

Administration / exposure

Type of coverage:
open
Vehicle:
other: see Test Formulation, above
Duration of exposure:
24 hours
Doses:
10 mg/cm2, 2.54 cm2 exposure area, and a receptor volume of approximately 4.5 ml. Since the test material was a thick liquid, the doses were applied to the skin and spread over the surface using pipette tips and the weight of the applied dose recorded after spreading

Results and discussion

Percutaneous absorption
Dose:
10 mg/cm2 of a test formulation containing 12% carbon black
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 24 hours

Applicant's summary and conclusion

Conclusions:
Carbon black particles did not penetrate into or beyond the surface layers of human Stratum Corneum following application of a cosmetic formulation.
Executive summary:

A GLP dermal penetration study was performed using the OECD 428 protocol with full-thickness human skin samples and transmission electron microscopy for semi-quantitative evaluation of dermal permeation. No permeation of carbon black particles from a cosmetic eyeliner formulation into or beyond the outer layer of the strateum corneum was found.

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