Registration Dossier
Registration Dossier
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EC number: 416-740-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Repeated Dose Oral, 1 key study - NOAEL=1000mg/kg/d in rats (according to OECD TG 408)
Repeated Dose Dermal-Testing not required based on Column 2 Annex IX
Repeated Dose Inhalation-Testing not required based on Column 2 Annex IX
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
There are limited but adequate data for the assessment of systemic toxicity following repeated exposure to the submission substance. Based on these data, the submission substance is expected to have a low potential for toxicity.
Oral: One key repeated dose study was located for the submission substance. This study was performed according to currently established OECD guidelines. Following 90 days of oral exposure (via gavage), the NOAEL for rats was determined to be 1000mg/kg/day (the highest dose tested). There was no mortality during the study. The test material did no produce any changes in physical observations, body weights, food consumption, motor activity levels, function observational batteries, organ weights or macroscopic and microscopic pathology evaluations.
Inhalation: In accordance with Column 2 of REACH Annex IX, repeated dose toxicity testing via the inhalation route is not necessary for the submission substance as this exposure route is not the most appropriate route of administration, having regard to the likely route of human exposure.
Dermal: In accordance with column 2 of REACH Annex VIII, a repeated dose toxicity test via the dermal route is not required because the physicochemical properties of the test substance do not suggest a significant rate of absorption through the skin.
Justification for classification or non-classification
Based on the available data, the submission substances are not expected to produce toxicity following repeated exposure. Therefore, these findings do not warrant classification of the test material for target organ toxicity (repeated exposure) under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP), under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations, or under the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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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