Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Two sensitisation studies with guinea pigs were available for assessment. In a Magnusson-Kligman maximisation test (equivalent or similar to OECD guideline 406), 1% MTBE-water solution was used for induction intracutaneously (Inveresk Research International, 1979b). One week later, an occlusive topical induction was performed with 1% MTBE-water solution. The topical induction phase lasted 48 hours. After a pre-test with various challenge concentrations, the animals were challenged topically with a 1% MTBE-water solution 14 days after the epicutaneous induction. No skin sensitisation was reported.

In the other study, ten guinea pigs were induced with an initial induction of 0.5 ml MTBE in saline. Every second day for the next three weeks, the animals received an intradermal injection of 0.1 ml MTBE in saline for a total of ten injections. (Litton Bionetics Inc., 1980a; ARCO Chemical Company, 1980). Fifteen days after the last injection, the guinea pigs received an intracutaneous challenge injection (0.05 ml of 0.1% solution of MTBE) below the sensitisation site. Skin reactions in the MTBE-group varied from slight to well defined erythema with occasional oedema. MTBE was not considered sensitising.


Migrated from Short description of key information:
MTBE is not a skin sensitiser in guinea pigs and there are no positive human data reported.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No information available. However, respiratory tract sensitisation is not expected since MTBE is not a skin sensitiser and no human data indicative of an effect are known. In addition, no evidence of inflammatory changes indicative of sensitisation were reported in repeated exposure inhalation studies in animals.

Justification for classification or non-classification

In accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.