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EC number: 268-625-3
CAS number: 68131-72-6
The substance is not classified for human health.
The substance showed some evidence of mild dermal irritation in two skin irritation studies. However, a DNEL for acute/short-term local effects was not able to be derived from these studies.
The only DNELs derived are for long-term systemic effects for dermal and inhalation routes, which have been derived in order to assess risks from worker exposure.
The result used to derive these DNELs was the NOAEL result of 1000 mg/kg bw/day for systemic toxicity, obtained from the OECD 422 Oral (Gavage) Combined Repeat Dose Toxicity Study With Reproduction / Developmental Toxicity Screening Test in the Rat.
The corrected dose descriptor of 875.0 mg/m3for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment,Chapter R.8: Characterisation of dose [concentration]-response for human health.
The conversion of an oral rate NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (of the above guidance) for workers (in the case of 8 hour exposure/day). This corrected dose descriptor was based on worst case assumptions for absorption (i.e. the absorption percentage for the oral route is half that for the inhalation route). The inclusion of this factor means that 50% absorption was assumed for oral absorption and 100% absorption assumed for inhalation. This leads to the most conservative corrected dose descriptor.
Default parameters for rats and human (for 8 hour exposure) were used for the allometric scaling principle.
DNELs have not been derived for the general public as there will be no exposure to the general public/consumers.
The substance will only be used by industry and not by the public. Due to minimal release of the substance from industrial use, exposure to the general public is not anticipated.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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