Registration Dossier
Registration Dossier
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EC number: 813-358-5 | CAS number: 4886-26-4
Endpoint summary
Administrative data
Description of key information
three Guideline studies according to OECD in vitro Testing Scheme are available.
However the results of these studies are of limited use for hazard assessment as the substance is unstable in the chosen solvent and degrades fast. Among the degradation products, Aniline is liberated which is a known skin sensitizer. However it is not conclusive whether the observed positive results are caused solely by Aniline or by other not further characterised degradation products obtained under the test conditions. The usability of the results of these tests is therefore not given.
one Guideline study on in vivo testing available and used for assessment.
no studies on respiratory sensitisation available.
Assessment can be done based on molecular structural features.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
initially two in vitro/in chemico studies were performed in accordance with the testing scheme set up based on OECD AOP on skin sensitisation.
One study result was negative for skin sensitizing properties whereas the second study result was positive.
Consecutively, a third in vitro study was performed and a positive result was obtained.
After careful assessment of the in vitro study methods and performing stability tests with the substance in the used solvent (Dimethylsulfoxide, DMSO)
it was concluded that use of the solvent DMSO in the two positive in vitro tests decreased the stability of the substance and degradation occured. However only DMSO can be used as vehicle in the used in vitro cell assays. Among the degradation products Aniline was present, which is a well known skin sensitiser.
To further investigate the potential of the substance for skin sensitisation, an in vivo Local Lymph node Assay was performed as the in vitro assays could not descriminate between the effects of the substance itself or its degradation products, formed under the test conditions.
For the performance of the LLNA a solvent was chosen, which does not decrease the stability of the substance.
The results of the LLNA indicate not potential for skin sensitisation for the substance itself.
The foreseen use conditions of the substance (i.e. choice of solvent in solvent based processes) are not expected to decrease the stability of the substance
and degradation is not expected.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
According to "Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, European Chemicals Agency, 2017",
Figure R.7.3–4 Assessment strategy for respiratory sensitisation data, the assessment of the substance concludes to "The substance is not a respiratory sensitiser"
Justification for classification or non-classification
The available information is conclusive but not sufficient for classification.
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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