Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 September - 27 October, 2011
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
other: ISO 10993-12:2007 "Sample preparation and reference materials"
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Constituent 1
Reference substance name:
Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)
EC Number:
700-869-2
Molecular formula:
Not applicable
IUPAC Name:
Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name: CarboNeXT
Colour: greyish
Storage conditions: at room temperature, protected from light

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
25%, 50% (v/v) and 100% (undiluted)
No. of animals per dose:
20 animals in the main test

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: see Remark
Remarks:
None of the three tested concentrations of the item reached the stimulation index of 3. The stimulation index at a concentration of 25% was 0.8 The stimulation index at a concentration of 50% was 0.8 The stimulation index at a concentration of 100% was 1.0 All animals survived throughout the test period without showing any clinical signs.

Any other information on results incl. tables

Body weight development

All animals showed the expected weight development, which includes a weight loss of up to 2g throughout the study.

Measurement of ear thickness

Directly prior to the first application, approximately 48 hours after the first application and shortly before excising the lymph nodes the thickness of both ears from all animals was measured.

The means of the ear thickness per group showed no significant difference compared to the negative control.

The mean ear thickness on

Day 1

Day 2

Day 3

for 25% test group was

0.18 mm

0.21 mm

0.20 mm

for 50% test group was

0.18 mm

0.20 mm

0.20 mm

for 100% test group was

0.18 mm

0.20 mm

0.20 mm

for the negative control group was

0.19 mm

0.19 mm

0.21 mm

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The EC3 value (derived by linear interpolation) could not be calculated as the stimulation indices of all concentrations were below 3.
The results of radioactivity determination were supported by the means of the ear thickness per group, which showed no significant difference compared to the negative control.
Consequently, according to OECD 429 the test item CarboNeXT as described in this report is expected to have no sensitising properties and therefore should not be regarded as a dermal sensitiser.
According to Commission Regulation (EU) No. 286/2011 as well as GHS the test item CarboNeXT has no obligatory labelling requirement for skin sensitation and is unclassified.