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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 2 to August 4, 2011

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

GLP compliance:

yes

Remarks on result:

no indication of irritation

INTERPRETATION OF RESULTS

According to EU classification, the irritancy potential of test substances is predicted for distinguish between R38 skin irritating and no-label (non skin irritating) test substance OECD 404 and Regulation (EC) No 1272/2008. In this study the irritancy potential of test substances is predicted by mean tissue viability of tissues exposed to the test substance.

The test substance is considered to be irritant to skin (R38), if the mean relative viability after 42 minutes exposure and 42 hours post incubation is less or equal to 50% of the negative control.

 

ACCEPTABILITY CRITERIA

The negative control data meet the acceptance criteria if the mean OD value of the 3 tissues at 570 nm is:

1.2 ≤ OD ≤ 2.5

The positive control data meet the acceptance criteria if the mean viability, expressed as % of the NC, is ≤ 40%.

In both case, the standard deviation value will be considered valid if it is ≤ 18% according to the performance standard (ECVAM SIVS, 2007).

 

RESULTS

Optic density (OD) at 570nm

REPLICA	1	2	3	4	5	6	7	8	9
Black	0.089	0.092	0.089	0.088	0.087	0.089	-	-	-
Negative Control	1.535	1.614	1.638	1.61	1.592	1.461	1.54	1.536	1.544
Positive Control	0.124	0.13	0.123	0.131	0.12	0.122	0.128	0.121	0.122
Sample	1.37	1.462	1.473	1.462	1.452	1.448	1.431	1.426	1.407

 

	Average OD	Acceptability	Result	SD%	Acceptability (%)	Result
Negative Control	1.47	1.2 ≤ OD ≤ 2.5	Complying	3.519	≤ 18	Complying
Positive Control	2.43	< 40 %	Complying	3.200	≤ 18	Complying

 

SAMPLE	% VIABILITY	ACCEPTABILITY
CarboNeXT	91.68	> 50%

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance must be considered NOT IRRITANT for the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 7, 2011

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

Irritation parameter:

cornea opacity score

Value:

2.88

Remarks on result:

no indication of irritation

The eye irritancy potential of CarboNeXT was investigated in the bovine corneal opacity and permeability assay.

The test item was diluted with physiological saline 0.9% NaCl to gain a 20% concentration.

The following mean in vitro score was calculated: 2.88

Therefore the test item was classified as non irritant.

Interpretation of results:

GHS criteria not met

Conclusions:

According to the evalutation criteria the test item CarboNeXT is classified as non eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available