Registration Dossier

Administrative data

Description of key information

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.

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

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.

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.

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.

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 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.