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:

An OECD guideline study was conducted to determine the sensitising potential of the read-across substance C16 TMAC (active ingredient 30%) in guinea-pigs according to the Buehler method. A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1-15), the test animals were exposed to 0.5 mL of the test substance at 4% w/v via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% w/v via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals were comparable to that of the controls. Under the conditions of the test, the substance was considered to be non-sensitising (Bury D, 1994).

A study was conducted to determine the sensitizing potential of the read-across substance C18 TMAC (70.8% active ingredient) in guinea-piga according to the Buehler test protocol (OECD guideline 406 and EU Method B6). A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1 - 15), the test animals were exposed to 0.5 mL of the test substance at 4% via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the induction phase(Days 1 - 15), animals presented light to clearly defined erythema and very light to clearely defined edema. The skin surfaces were dry and flaky. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls. Under the conditions of the Buehler test, thesubstance is considered to be non-sensitizing (Bury D, 1995).


Migrated from Short description of key information:
The available in vivo skin sensitisation studies on read substances C16 TMAC and C18 TMAC are not skin sensitisers and therefore based on the read-across approach, C16-C18 TMAC is also not expected to be a skin sensitiser.

Justification for selection of skin sensitisation endpoint:
Both studies are considered relevant for the chemical safety assessment since the one study is conducted on C16 TMAC and the other on C18 TMACReliable, guideline equivalent study conducted with required number of animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non-respiratory sensitisation of the substance. The substance is a solid with a low vapour pressure. Due to it physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e. g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.


Migrated from Short description of key information:
As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non-respiratory sensitisation of the substance. The substance is a solid with a low vapour pressure. Due to it physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e. g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for selection of respiratory sensitisation endpoint:
As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative outcome for dermal sensitisation is also predictive for non-respiratory sensitisation of the substance. The substance is a solid with a low vapour pressure. Due to it physical state and physical chemical properties, it is unlikely that it will form inhalable dust, mist or fumes when handled and used in solid form. In case inhalable forms of the substance (either pure or in aqueous solutions) are created under particular conditions (e. g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for classification or non-classification

Read across substances C16 TMAC and C18 TMAC did not cause skin sensitisation reactions in guideline studies. Based on the adopted read-across approach C16 -C18 TMAC, is also not likely to be a skin sensitiser and therefore no classification is required for sensitisation according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).