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EC number: 947-972-0 | CAS number: -
An acute oral study on rats was performed according to OECD 425 guideline and GLP. The oral LD50 value was established to exceed 2000 mg/kg body weight. Based on these results, the substance does not have to be classified for acute toxicity according to the CLP Regulation.
Trimethyl hexamethylene Diisocyanate, a reactant, remains present at a concentration of 8% after the substance is manufactured. Trimethyl hexamethylene Diisocyanate has a health hazard classification, acute (inhalation) toxicity (H330), that has not been investigated because there is no requirement to do so in accordance with Annex VII of the REACH Regulation.
Body weights (gram):
The objective of the study was to determine the potential toxicity of Thio Isocyanate Adduct, when given by oral gavage at a single dose to rats of a single sex at one or more defined doses to evaluate the potential reversibility of any findings. The study was carried out in compliance with OECD guidelines 425. Initially, Thio Isocyanate Adduct was administered by oral gavage to one female Wistar rat at 2000 mg/kg body weight. Based on the absence of mortality, four additional female Wistar rats were dosed at 2000 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Piloerection was noted for four out of five animals on Day 1. The body weight gain shown by the animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals.
The oral LD50 value of Thio Isocyanate Adduct in Wistar rats was established to exceed 2000 mg/kg body weight.
Based on these results, Thio Isocyanate Adduct does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
The oral LD50 value was established to exceed 2000 mg/kg body weight. Based on these results, the substance does not have to be classified for acute toxicity according to the CLP Regulation No 1272/2008.
While there is no requirement to provide information on acute toxicity, via the inhalation route, an acute toxicity estimate can be calculated.
The acute toxicity estimation of the reactant, Trimethyl hexamethylene Diisocyanate (EC 915 -277-1), is 0.05 mg/l.
The acute toxicity (inhalation) estimation of the registered substance is 0.625 mg/l. For this reason, the substance has been classified as "Acute Tox. 3" with the hazard statement for a "H331: Toxic if inhaled", according to the CLP Regulation No 1272/2008.
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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