Registration Dossier

Administrative data

Description of key information

The only available study is the oral LD50 study which shows LD50 to be >2000 mg/kg.  As 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol is a skin irritant but not corrosive, dermal absorption would be expected to be lower than oral, so the LD50 would also be expected to be > 2000mg/kg.  There is no study for an inhalation LC50, but the physical form of the substance as a waxy solid at ambient temperatures and its low vapour pressure mean that an inhalation LC50 study is not scientifically justified as inhalation exposure is not anticipated.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available study is acceptable for classification and labelling purposes being of Klimisch 2 validity, there were some deaths seen at 2000 and 5000mg/kg but the oral LD50 was greater than 2000mg/kg so it is not classified based on EU CLP(GHS) it is however classified as Category V for acute toxicity for the Global GHS purposes.

There is no dermal LD 50 value as we have no data for acute skin toxicity of 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787 -30-4 or the main read across substance 2,2’-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 due to its corrosive properties to skin. But due to the skin irritant nature of the substance it is not ethical to carry out this animal study. The irritant classification of the 2,2’-(C16-18 (evennumbered), alkyl imino) diethanoland the required risk management methods with minimise the potential for skin contact, so the lack of a dermal LD50 will not affect the safe handling of the substance . The physical properties of the substance as a waxy solid with a relatively high Log octanol water partition coefficient of 3.6, will reduce the potential for skin absorption so it is expected that the dermal LD50 would higher than the oral LD50 which itself was >2000 mg/kg i.e. not classified for EU CLP(GHS).

We have no inhalation LC50 data for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4, however it is a waxy solid with a low vapour pressure 0.73 mPa at 20ºC (1.2 mPa at 25ºC), significant exposure to vapours would not be expected at ambient temperatures so the lack of an inhalation LC50 is not considered significant as inhalation is not an expected route of exposure.

Due to the physical form of the 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4being a waxy solid at ambient temperature, the is no aspiration hazard for this substance

Justification for selection of acute toxicity – oral endpoint

The available study is acceptable for classification and labelling purposes being of Klimisch 2 validity, there were some deaths seen at 2000 and 5000mg/kg but the oral LD50 was greater than 2000mg/kg so it is not classified based on EU CLP(GHS) it is however classified as Category V for acute toxicity for the Global GHS purposes.

Justification for selection of acute toxicity – inhalation endpoint

We have no inhalation LC50 data for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4,  however it is a waxy solid with a low vapour pressure 0.73 mPa at 20ºC (1.2 mPa at 25ºC), significant exposure to vapours would not be expected at ambient temperatures so the lack of an inhalation LD50 is not considered significant as inhalation is not an expected route of exposure.

Justification for selection of acute toxicity – dermal endpoint

There is no dermal LD 50 value as we have no data for acute skin toxicity of 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4 or the main read across substance 2,2’-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 due to its corrosive properties to skin.  For the but due to the skin irritant nature of the substance it is not ethical to carry out this animal study. The irritant classification of the 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol and the required risk management methods with minimise the potential for skin contact, so the lack of a dermal LD50 will not affect the safe handling of the substance .  The physical properties of the substance as a waxy solid with a relatively high Log octanol water partition coefficient of 3.6, will reduce the potential for skin absorption so it is expected that the dermal LD50 would higher than the oral LD50 which itself was >2000 mg/kg i.e. not classified for EU CLP(GHS).

Justification for classification or non-classification

The oral LD50 was established to be greater than 2000mg/kg, we do not have a dermal study but it would be expected to be less toxic by the dermal route, therefore valso > 2000mg/kg. We have no inhalation LC50 data for 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30 -4, however it is a waxy solid with a low vapour pressure 0.73 mPa at 20ºC (1.2 mPa at 25ºC), significant exposure to vapours would not be expected at ambient temperatures so the lack of an inhalation LC50 is not considered significant as inhalation is not an expected route of exposure.