Solid Recovered Fuel (Municipal Solid Waste and similar wastes, processed)

Skin sensitisation

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2600 (Skin Sensitisation)

Test guideline 4

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

Test material information

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

Results 1

Parameter:

SI

Value:

0.8

Test group / Remarks:

concentration of 50%

Results 2

Parameter:

SI

Value:

1

Test group / Remarks:

concentration of 100%

Results 3

Parameter:

SI

Value:

0.8

Test group / Remarks:

concentration of 25%

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:

GHS criteria not met

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.