Cyclohexane-1,2,4-triyltris(ethylene)

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

exposure considerations

Justification for data waiving:

a short-term toxicity study does not need to be conducted because relevant human exposure can be excluded as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
A short-term repeated dose toxicity study with the substance is considered not necessary and shall be omitted due to exposure considerations specified in the following.
The substance is registered according to Art. 10 due to its function as monomer. Due to its function as monomer the substance will be incorporated into a polymer matrix. No release of the monomer from the polymer matrix occurs. During all life-time stages the substance is kept rigorously contained and all handling steps are performed under strictly controlled conditions as specified in Art. 18 and briefly described in the following:
The vessels are closed during the reactions and work-up steps, all transfer of process liquids will be carried out through tightly connected pipes or with flexible hoses, tightly connected for the process for the time of the campaign. Tightness check is carried out before start of the campaign and transfer through tightly connected pipes and tightly connected hoses. Transfers using tank containers are done under closed conditions using tightly connected hoses and a suction connection. Off-gases are incinerated or filtered before emission by a high performance filter system.
The substance is delivered in drums or in tank containers. Thereby liquid substance is filled into tank containers via a suction connection or pumped into drums under closed conditions. Off-gases are incinerated.
The applied equipment for processing of the substance is cleaned within a closed system with appropriate cleaning solvents and finally with a last rinsed with water. All liquid streams (organic and aqueous) will be incinerated (internally on-site). After additional visual check, the equipment can be opened for dismantling or maintenance work.
All relevant staff is trained on the process to be able to carry out the correct activities in a controlled way. Furthermore only operators, trained on standard operating procedures will handle the processing steps.
Waste is generated during reaction, distillation and pastillation steps. Liquid waste is handled inside closed systems (closed vessels and tightly connected pipes) including transfer to incineration. All liquid streams (organic and aqueous) are incinerated (internally on-site). Solid waste is collected and also incinerated.
Thus, as the substance is rigorously contained and handled under strictly controlled conditions, relevant human exposure can be excluded and according to REACh Regulation (Annex VIII, section 8.6.1, second column) the study does not need to be conducted.