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EC number: 295-322-3 | CAS number: 91995-60-7
Based on the available human and animal data regarding TAME, the substance is not expected to be irritating to the skin, eyes and respiratory tract.
Based on the considerations described in the document "Read-across substantiation C5-6 branched alkylmethyl-ethers” (incl. the supporting references Tuppurainen et al., 2007 and Niska et al., 2008), it can be concluded that the available information of TAME can be used to predict the skin, eye and respiratory tract irritation properties of the substance ‘C5-6 branched alkylmethyl-ethers’ with sufficient certainty.
Eye irritating properties of TAME have been studied in a study with three albino rabbits following OECD Guideline 405 and performed under GLP (Bayer AG, 1991b). Slight redness and swelling of the conjunctiva were recorded; however, the effects were reversible after 7 days of instillation of the test substance.
No animal studies regarding respiratory tract irritation are available. In the acute inhalation toxicity study with TAME (exposure to 5400 mg/m3 for 4 hours, ITT Research Institute, 1991) rales were seen in all rats immediately following the exposure. The rales were present in 7/10 animals about 2 hours after the exposure, but 3 ¼ hours later all rats appeared normal. Redness around the nose was noticed in 7/10 rats during the study at 5400 mg/m3.
In a volunteer study with six humans (Pekari et al, 1997b, see section on acute toxicity for study summary), TAME caused only minor acute effects (exposure concentrations: 15 (60 mg/m3) and 50 (212 mg/m3)). Slight irritation of the eyes, nose and throat and drying of the mouth were reported. The effects were considered marginal and do not give reason to classify TAME for eye and respiratory tract irritation.
Based on the available data and in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification of TAME is not necessary for skin, eye and respiratory tract irritation.
Based on the proposed read-across approach, this non-classification does also apply for C5-6 branched alkylmethyl-ethers.
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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