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:

Skin sensitisation

A study was conducted to determine the sensitising potential of the test substance C12-14 alkyl trimethyl ammonium chloride. The chain length distribution is somewhat different compared with TMAC. However, the somewhat narrower chain length distribution does not influence the validity for the use of this study for the active substancein guinea-pigs. The test was equivalent to the Buehler test protocol (OECD Guideline 406).

A pre-test was conducted to determine non-irritating concentrations to use in the main study. For the main study the induction was carried out at: topical 0.1% w/v in aqueous ethanol for 6 hours, repeated after 7 and 14 hours. Challenge was done two weeks after last induction treatment, test controls and test animals on the untreated side received 0.1% w/v in acetone for 6 hours under closed patches. After 18 hours the sites were treated with depilatory cream, rinsed and dried, and scored (0-3) after 3 hours.

Results of the first grading were: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals)

The test substance tested has a narrower chain length distribution compared to full coco. The results from this substance however were fully valid for evaluation of TMAC as:

-The tested substance constitutes already for 70% TMAC, without some additional shorter and longer chain lengths present..

Principally, aspects of sensitisation are related to possible reactivity and protein binding, which are properties that are independent to chain length.

Under the conditions of the Buehler test, thetestsubstance is considered to be non-sensitizing (Jones JR, 1978).


Migrated from Short description of key information:
No skin sensitisation reactions were observed when C12-C18 TMAC was tested in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Guideline study available on the test substance.

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

No skin sensitisation reactions were observed in a guinea pig Buehler test, therefore, no classification is required for sensitisation according to EC DSD criteria (67/548/EEC) and EC CLP criteria (EC 1272/2008).