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EC number: 290-611-0 | CAS number: 90194-04-0
The toxicity of 1,3-Benzenedimethanamine, reaction products with glycidyl tolyl was investigated with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 15 mg/kg bw/day. The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 25 mg/kg bw/day.
Since only a sub-chronic oral toxicity study is available a route-to-route extrapolation is needed to derive the DNELs for dermal and inhalation routes. According to Chapter R.8 of REACH Guidance on information
requirements and chemical safety assessment, it is proposed in the absence of route specific information on the starting route, to include a default factor of 2 in the case of oral-inhalation extrapolation. On the assumption, that in general, dermal absorption will not be higher than oral absorption, no default factor is introduced for the oral to dermal extrapolation. The REACH Guidance on information requirements and chemical safety assessment (R.8.4.2) prescribes a default factor of 1 in case of oral to dermal extrapolation. This approach will be taken forward to DNEL derivation.
15/2 (absorption rate) / 0.38 m3/kg bw = Inhalation NOAEL Rat of 2.85 mg/m3 (8h)
NOAEC = 2.85 x 0.67 = 1.91 mg/m3)
1,3 -Benzenedimethanamine, reaction products with glycidyl tolyl is classified as a Cat 1 sensitizer, as a consequence and in accordance with Part E Table E.3 -1 of the ECHA guidance the registered substance is allocated to the High Hazard band and qualitative assessment will be required as it is not possible to derive a threshold dose for sensitization.
The substance is not intended to be marketed for consumer use.
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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