Registration Dossier
Registration Dossier
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EC number: 275-148-4 | CAS number: 71033-19-7
Endpoint summary
Administrative data
Description of key information
Skin: not irritating, not corrosive
Eye: not irritating, not corrosive
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:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
The potential of the test item to be irritant to the skin was investigated through an in vitro skin irritation study using a commercial reconstructed human epidermis (RhE) model named EPISKIN™. The experimental procedures are based on the OECD Guideline for testing of chemicals no. 439, in GLP.
The test item did not induce cell death in any replicate, the mean cell viability after appropriate subtraction was 105.5% when compared to the negative control. The substance is considered not irritant to the skin.
Eye irritation/corrosion
An vitro study was performed to assess the corneal damage potential of the substance, according to the OECD Guideline for the Testing of Chemicals, Method No. 437 and the EU Method B. 47, in GLP.
Under the conditions of this study, the test item showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 21.97.
Justification for classification or non-classification
Skin irritation/corrosion
Three in vitro skin irritation test methods based on reconstructed human epidermis (RHE) technology have been recently accepted by the OECD in the OECD TG 439. They serve to reliably distinguish non-irritants from irritant substances.
The EpiSkinTM and EpiDermTM assays have undergone formal ECVAM validation from 2003–2007 (Spielmann et al, 2007).
In 2007 the EpiSkinTM assay was considered valid by ESAC as a full replacement test (ECVAM/ESAC, 2007).
According to the Decision logic for classification of substances ( Guidance on the Application of the CLP Criteria, June 2015), data from a suitable in vitro test, and existing and relevant data can provide sound conclusive evidence that the substance is an skin irritant or non irritatant substance. According to the results of the test OECD 439, and the CLP Regulation n. 1272/2008, the substance can be not classified as a skin irritant/skin corrosive.
Eye irritation/corrosion
The OECD has at present adopted three in vitro tests for the identification of substances inducing serious eye damage, i.e. the Isolated Chicken Eye (ICE) test (OECD TG 438; TM B.48), the Bovine Corneal Opacity and Permeability (BCOP) test (OECD TG 437; TM B.47) and the Fluorescein Leakage (FL) test (OECD TG 460). These tests are recommended for use as part of a tiered-testing strategy for regulatory classification and labelling (e.g. Top-Down Approach).
Negative results from the ICE and BCOP test methods can be used for classification purposes i.e. ‘bottom-up approach’.
Under the conditions of this study, the test item showed effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 21.97. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, but cannot be classified in an UN GHS Category (no prediction can be made).
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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