Registration Dossier
Registration Dossier
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EC number: 916-226-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
For the evaluation of the skin corrosion/irritating properties of Katalysator WAZ 5596 B an artificial 3D-skin model test according to OECD TG 439 was used.
An in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was conducted. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France). Additionally Katalysator WAZ 5596 B was tested using the Hen's egg chorioallantoic membrane (HET-CAM) test according to the ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM Recommended Protocol for Future Studies Using the Hen's Egg Test-Chorionallantoic Membrane (HET-CAM) Test method, November 2006.
Key value for chemical safety assessment
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the in-vitro 3D skin irritation test Katalysator WAZ 5596 B was irritating - but not corrosive.
In the reconstituted human ocular epithelia (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France) Katalysator WAZ 5596 B was irritant. Also in the HET-CAM test using the chorionallantoic membrane (HET-CAM, 8d incubation) of chicken eggs Katalysator WAZ 5596 B was irritant.
Justification for selection of skin irritation / corrosion endpoint:
For the evaluation of the skin corrosion/irritating properties of Katalysator WAZ 5596 B an artificial 3D-skin model was used. Both studies are used for classification to differentiate if the substance is corrosive or irritant.
Justification for selection of eye irritation endpoint:
For the evaluation of the eye irritant properties of Katalysator WAZ 5596 B a test using a human epithelial corneal cell model and a HET-CAM test was used.
Both studies are used for classification to differentiate if the substance is irritant to the eyes or causes serious eye damage.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Due to the positive result of the in-vitro skin irritation test R38 (GHS: skin irritation category 2) is adequate.
In the HCE test Katalysator WAZ 5596 B was an ocular irritant under the conditions of this test method. In the following HET-CAM test Katalysator WAZ 5596 B was identified as "strong irritant" to the chorioallantoic membrane (Irritation Score (IS) = 10) under the conditions of this assay. Therefore a classification as R41 (GHS: eye irritation category Cat 1) is justified.
In addition, respiration irritational effects were reported in the acute inhalation study (Pauluhn, 2012) for. Therefore R 37 (GHS: STOT Single Exp. 3; H335: May cause respiratory irritation) is applicable.
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