Registration Dossier
Registration Dossier
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EC number: 939-705-1 | CAS number: 2867-59-6
Endpoint summary
Administrative data
Description of key information
In vitro Corrositex®: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Additional information
In vitro Skin Corrosion Test
The potential of 3-Amino-butan-1-ol to cause dermal corrosion was assessed by a single topical application of 500 μL of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay) (OECD 435). In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The mean break through time of the test substance, determined in the actual Corrositex® assay, was 28 minutes and 18 seconds. Based on the observed results and applying the evaluation criteria it was concluded, that 3-Amino-butan-1-ol shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. [BASF, 2014]
The potential of 3 -Amino-butan-1-ol of the skin corrosion/irritation potential was assessed by a single topical exposure of 50 μL of the test substance to the surface of a human reconstituted epidermis model (EpiDerm TM) for 3 minutes and 1 hour followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of the yellow, water-soluble MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide), present in cell mitochondria, into a blue formazan salt that is measured quantitatively after isopropanol - extraction from the tissues. The optical density of the extracts of test substance treated tissues is compared to negative control values from tissue treated with highly de-ionized water and is expressed as relative tissue viability.
The EpiDerm TM skin corrositivity/irritation test showed the following results: Corrosion test: Teh mean viability of the test -substance treated tissues determined after an exposure period of 3 minutes was 25 % and it was 11% after an exposure period of 1 hour. Based on the observed results it was concluded, that 3 -Amino-butan-1 -ol shows a skin corrosion potential in the EpiDerm TM skin corrosion test under the test conditions chosen. [BASF, 2014]
Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
EU classification according to Annex I of Directive 67/548/EEC: C, R34
According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 subtance is classified as Cat. 1B Causes severe skin burns and eye damage
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