Registration Dossier
Registration Dossier
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EC number: 700-163-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion: corrosive
Eye irritation/corrosion: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
An in vitro study was performed to assess the corrosive potential of the test substance by means of the In Vitro Membrane Barrier Test for Skin Corrosion using the Corrositex™ test kit (Heppenheimer, 2010).
The test item passed the qualify test and was considered as suitable for testing with the Corrositex™ test kit.
The test item induced a colour change in the category B vial, but not in the Category A vial after 1 minute incubation. Therefore, the test item was classified according to category I.
500μL of the test item were applied on quadruplicate bio-barriers for the classification test. The bio-barriers were placed atop vials containing the CDS reagent. The time needed to corrode the bio-barrier and induce a distinct change in the colour of the CDS reagent was monitored for each of the vials.
500μL of the negative control (10% citric acid) or 500 µL the positive control (Sulfuric acid 95-98%) was placed atop one bio-barrier and the colour change of the CDS reagent was monitored up to 240 minutes. The negative control did not induce a change in the colour of the CDS reagent after 240 minutes. The positive control showed a distinct change in the colour of the CDS reagent after 1minute 7 seconds incubation. These results ensured the validity of the test.
The mean time needed to change the colour of the CDS reagent after treatment of the bio-barriers with the test item was 77 minutes 41 seconds. According to the classification criteria the test item was classified as corrosive and placed in packing group III (R34, GHS 1C).
This study is considered as acceptable as it satisfied the criteria of OECD guideline.
Eye irritation/corrosion:
In accordance with column 2 of REACH Annex VIII, the in vivo eye irritation study (required in section 8.2.1) does not need to be conducted as the substance is classified as corrosive to the skin based on the results of the in vitro membrane barrier test for skin corrosion (Heppenheimer, 2010).
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
According to the results of the key study, the substance is classified for irritation/corrosion as:
- Skin Corr. 1C (H314, Cause severe skin burns and eye damage) according to the criteria of the Regulation (EC) No. 1272/2008 (CLP)
- Corrosive (C; R34) according to the criteria of the Council Directive 67/548/EC and its subsequent adaptations.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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