Registration Dossier
Registration Dossier
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EC number: 940-005-3 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test substance Reaction product of Saccharose, Glycerine, biodiesel propoxylated was tested for dermal irritation in a reconstructed three dimensional human epidermis model (EpiDerm™) and for ocular irritation in a reconstructed three dimensional human cornea model (EpiOcular™).
In the EpiDerm™ test, 3 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 mean viability of the test-substance treated tissues determined after exposure and post-incubation was 113% relative to the negative control.
In the EpiOcular™ test, 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 mean viability of the test-substance treated tissues was 86% relative to the negative control.
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
Justification for classification or non-classification
Based on the observed in vitro results it was concluded, that Reaction product of Saccharose, Glycerine, biodiesel propoxylated does not show a skin irritation or eye irritation potential. Classification according to Regulation (EC) 1272/2008 is not warranted.
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