Registration Dossier
Registration Dossier
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EC number: 701-027-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Based on the available human and animal data, TAME is not irritating to the skin, eyes and respiratory tract.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
TAME did not cause skin irritation in a study conducted on three albino rabbits under semi occlusive dressing following OECD Guideline 404 and performed under GLP (Bayer AG, 1991a). All scores for erythema and oedema formation were zero at all time points.
The eye irritation potentail of TAME has 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 within 7 days of instillation of the test substance.
No animal studies regarding respiratory tract irritation are available. In the acute inhalation toxicity study (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.
The inhalation repeated dose toxicity studies with rats and mice do not trigger a concern for respiratory tract irritation.
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.
Justification for classification or non-classification
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 is not necessary for skin, eye and respiratory tract irritation.
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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