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Description of key information

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

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)
Irritation parameter:
other: opacity
Basis:
mean
Time point:
other: 90 minutes
Score:
2.88
Reversibility:
fully reversible

The eye irritancy potential of CarboNeXT was invistigated 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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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

Additional information

Justification for classification or non-classification