Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Product: CarboNeXT
Physical state: solid
Batch: 08-07-2011

Results and discussion

Any other information on results incl. tables

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%

 

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance must be considered NOT IRRITANT for the skin.