Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin:
- Skin irritation, EpiDerm™ skin irritation test, OECD 439: viability 89-114%, non-irritant (BASFSE, 2012, 61V0072/12A112)
Eye:
- Eye irritation, EpiOcularTM Eye Irritation Test, according to MatTek 2010/ Harbell J.W. et al. (2009): viability 98.7-104.6%, non-irritant (BASFSE, 2012, 62V0072/12A113)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are valid in vitro study data available assessing the irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated to skin and eye. There are not in vivo studies available or proposed due to Annex XI, Section 1.4 (see waiver statement)

Skin:

 

OECD guideline conform studies:

The potential of the test substance to cause dermal irritation was assessed by a single topical application of 30μL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™)(BASFSE, 2012, 61V0072/12A112). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability. The EpiDerm skin irritation test showed the following results: The test substance is able to reduce MTT directly. The mean viability of the test substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 114%. As visible residues of the test substance were observed on the tissues after washing an influence of the test substance due to direct MTT reduction had to be excluded. Therefore a second test run was performed with an additional MTT reduction control. The mean viability of the test substance treated tissues for the 2nd test run was 89%. The ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing used during the 2nd test run. Based on the observed results and applying the evaluation criteria cited in chapter 3.8 it was concluded, that Fatty acids, C18-unsatd., dimers, ethoxylated does not show a skin irritation potential in the EpiDerm™ skin irritation test under the test conditions chosen.

Key study assignment skin irritation:

As there is only one relevant and reliable study available assessing the skin irritation of Fatty acids, C18-unsatd., dimers, ethoxylated and no further results are available, this study is therefore included as key study.

Assessment skin irritation:

All available information is taken into account to assess the skin irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated. The results are derived from a scientific valid in vitro method show a cell viability of 89-114%, hence the substance is considered as non-irritant.

Eye irritation:

other guideline conform studies:

The potential of Fatty acids, C18-unsatd., dimers, ethoxylated to cause ocular irritation was assessed by a single topical application of 50μL of the test substance to a reconstructed three dimensional human cornea model (EpiOcular™) according toMatTek 2010/Harbell J.W. et al. (2009) (BASFSE, 2012, 62V0072/12A113). Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results: The test substance is able to reduce MTT directly. However, this ability of direct MTT reduction did not impair the study result as demonstrated by the concurrently performed exposure of control tissues inactivated by freezing. The mean viability of the test-substance treated tissues was 102%. Based on the observed results and applying the evaluation criteria it was concluded, that Fatty acids, C18-unsatd., dimers, ethoxylated does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.

Key study assignment skin irritation:

As there is only one relevant and reliable study available assessing the eye irritation of Fatty acids, C18-unsatd., dimers, ethoxylated and no further results are available, this study is therefore included as key study.

Assessment eye irritation:

All available information is taken into account to assess the eye irritating potential of Fatty acids, C18-unsatd., dimers, ethoxylated. The results are derived from well-known highly reliable in vitro eye irritation test (EpiOcularTM Eye Irritation Test) show a cell viability of 98.7-104.6%, hence the substance is considered as non-irritant.


Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study.

Justification for selection of eye irritation endpoint:
GLP compliant and current methods followed study.

Justification for classification or non-classification

Skin:

Based on the available information from skin irritation study were no hints for irritation were observed, the substance has not be classified according to EU, UN-GHS (EC 1272/2008 ) or DSD (67/548/EEC).

Labelling for skin irritation:

GHS: no classification

DSD: no classification

 

Eye:

Based on result of the eye irritation study to the test substance, classification and labelling is not warranted according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.

Labelling for eye irritation:

GHS: no classification

DSD: no classification