Registration Dossier

Administrative data

Description of key information

Results of an in vitro skin corrosion/irritation study on wheat glucose syrup performed according to test guidelines have demonstrated that the compound is not a skin irritant (Höpfner, 2010). 
In accordance with section 1 of REACh (Regulation (EC) No 1907/2006) Annex XI, the in vivo skin irritation study (required in Annex VIII section 8.1.1) is not scientifically necessary as the in vitro EpiSkin study is valid for the classification of substances for skin irritancy according to CLP criteria; further testing on vertebrate animals for skin irritation shall be omitted.

Key value for chemical safety assessment

Skin irritation / corrosion

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

Additional information

An in vitro skin corrosion/irritation study on wheat glucose syrup was identified, which was performed according to OECD Guidelines for the Testing of Chemicals 431 (in vitro skin corrosion: human skin model method) and 439 (in vitro skin irritation: reconstructed human epidermis test method) and in compliance with GLP (Höpfner, 2010). 

In the skin corrosion study, 25 mg of finely grounded dried wheat glucose syrup with 25 µL of water was applied to the human skin model EpiDerm for 3 minutes and 60 minutes followed by a cell viability test {3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide (MTT) assay}. The test was performed in duplicate. Deionised water and 8N KOH were used as negative and positive controls, respectively. The positive control showed clear corrosive effects (mean tissue viability of 16.8% after 3-minute of exposure, which was lower than 30%, as required by the assay acceptance criteria). The mean absorbance values were 1.949 after 3-minute and 1.907 after 1-hour of exposure, which was higher than 0.8 as required by the assay acceptance criteria. In addition, the maximum inter tissue viability differences of the test substance treated skin discs were 1.6% for the 3-minute exposure and 6.7% for the 1-hour exposure, which is below 30% as required by the assay acceptance criteria. The relative absorbance values for the test substance were 97.8% after 3-minute exposure and 98.2% after 1-hour exposure, which were above the threshold for corrosion (50%). Therefore, dried wheat glucose syrup is considered as a non-corrosive substance in the in vitro Human Skin Model Test. 

In the skin irritation study, 25 mg of finely grounded dried wheat glucose syrup with 25 µL of water was applied to the human skin model EpiDerm for 60 minutes followed by a cell viability test {3-[4,5-dimethyl thiazole 2-yl] 2,5-diphenyl-tetrazoliumbromide (MTT) assay}. The test was performed in triplicate. Deionised water and 5% sodium dodecylsulphate (SDS) solution were used as negative and positive controls, respectively.  The positive control showed clear irritating effects (mean tissue viability of 6.1%, which is lower than 20%, as required by the assay acceptance criteria).  The absorbance values were within the required acceptability criterion of 1.0<mean optical density (OD)<2.5 and variation among replicates was acceptable for the negative control, positive control and the test item (<18%).  The mean relative absorbance value for the test item was 96.9%, which was above the threshold for irritation (50%). Therefore, dried wheat glucose syrup is considered as a non-irritant in the in vitro Human Skin Model Test. 

 

In accordance with section 1 of REACh (Regulation (EC) No 1907/2006) Annex XI, the in vivo skin irritation study (required in Annex VIII section 8.1.1) is not scientifically necessary as the in vitro EpiSkin study is valid for the classification of substances for skin irritancy according to CLP criteria; further testing on vertebrate animals for skin irritation shall be omitted.

Justification for classification or non-classification

Skin Corrosion / Irritation: According to the in vitro EpiSkin results, the notifiable substance is non-corrosive and non-irritating. According to the Guidance on the Application of the CLP Criteria (ECHA Reference ECHA-09-G-02-EN), the EpiSkin method is valid for the classification of substances for skin irritancy according to CLP criteria. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.2.

 

Serious Eye Damage / Eye Irritation: According to the in vivo OECD Guideline 405, Acute Eye Irritation / Corrosion results, the substance is non-corrosive and non-irritating.