INTERNAL

Amendment to „Assessment of skin sensitizing potential of capsules” dated May 20, 2009 

created by 

Dear 

Thank you for your request. Below you find the requested additional calculation based on the 

assessment created by 2009. 

The following assumption, are taken into account, as submitted via email.

1.) Skin sensitization is the most critical endpoint concerning consumer exposure.

2.) Data available given in „Assessment of skin sensitizing potential of capsules” dated May 

20, 2009 is still valid and no new data is added.

3.) Calculation assumtions for capsules are the same as given in the assessment.

4.) Residual is 15-100 ppm, average 50 ppm; calculation with worst case 100ppm

5.) Instead of pure (100ppm) a mixture called containing (400ppm) and 

 (CAS , 700ppm) is used as crosslinker. Therefore the “potential 

sensitizer” is the mixture (1100ppm).

6.) The sensitizing potential of and is assumed to be in the same.

7.) Density of is 1.18 g/mL at 25 °C and for Pentaerithritol tetraacrylat 1.19 g/mL at 25 °C.

8.) Density of is calculated as 7:4 mixture of the single density (rough approach 1.19 g/mL). 

NOAEC for :

Based on Annex I the NOAEC for 50% is calculated as 11750 μg /cm2

. 

NOAEC for PETIA:

Taken the assumption into account that has the same skin sensitizing potential to 

human than (which has a NOAEC of 0.3%) to following NOAEC for 0.3% is calculated:

0.3% x 10 x 1.19 x 25 = 89.3 μg /cm2 

Using the calculated 4.6 mg capsule / day from Annex II (Esch 2009) the following values for 

can be calculated: 

February 11, 2014

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INTERNAL

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Estimated exposure for :

For a residual monomer level of max. 100 ppm has been determined. In a worst case calculation it 

is assumed that in some cases the highest residual value may be released and that penetrates to 

100% through the skin. 

EXPMMA= 4.6 mg capsule/day x 100 ng /mg capsule

= 460 ng /day 

Taken the total expose skin area of 17600 cm2 into account the topical concentration of for 

calculation received from capsules results in

460ng /day/17600cm = 0.026 ng /cm2

Estimated exposure for :

For a residual monomer level of 1100 ppm has been determined. As already done for in 

Annex II (Esch 2009) also here a worst case dermal penetration for of 100% is assumed.

EXPPETIA= 4.6 mg capsule/day x 1100 ng /mg capsule

 = 5060 ng /day

Taken the total expose skin area of 17600 cm2 into account the topical concentration of for 

calculation received from capsules results in

5060ng /day/17600cm = 0.2876 ng /cm2

Margin of safety:

The margin of safety has been calculated by means of the ratio between the derived no-observed-adverseeffect-concentration (NOAEC) for skin sensitization and the estimated consumer exposure.

NOAEC skin sensitization 11750 μg/cm2 89.3 μg/cm2

Estimated consumer exposure 0.026 ng/cm2 0.2876 ng/cm2

Margin of safety 452 x 106 0.3 x 106

Risk Assessment:

As the received margin of safety is estimated well above the commonly used safety margins (e.g. 1000 

as mentioned in Goebel et al. 2012) it is considered very unlikely that skin sensitization to 

occurs from contact with capsules in fabric softeners.

Yours sincerely

Please note this document is an additional document to „Assessment of skin sensitizing potential of capsules” 

dated May 20, 2009 created by

Literature:

C. Goebel et al., Regulatory Toxicology and Pharmacology, Volume 63, Issue 1, June 2012, Pages 40–52