Registration Dossier

Administrative data

Description of key information

There are three acute oral toxicity studies, of which two are validity 2, the other being only supportive data.  In the study considered most relevant to the classification of this substnace the LD50 values (plus 95% confidence limits) were 1500 (1100-2000) mg/kg bw for males, and 1200 (900-1600) mg/kg bw for females. Based on a mean vlaue 1350mg/kg will be used for classification etc.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
1 350 mg/kg bw

Additional information

There are three studies available that have derived oral LD50 values of Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 now to be registered under 2,2’-(C16018 (evennumbered, C18 unsaturated) alkyl imino) diethanol CAS 1218787-32-6. None of the studies are of validity 1. Two of the studies are validity 2, and these form the basis of the acute oral LD50 for this substance. The most recent study was a CESIO study carried out in 1991 to OECD401, in this study Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4, was tested up to 2000mg/kg and no deaths were seen at this level. The vehicle in this study was arachis oil. In an older study carried out in 1984 to OECD Guideline 425 on Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 dose levels up to 5000 mg/kg were tested. This study showed a much higher levels of toxicity, The LD50 values (plus 95% confidence limits) were 1500 (1100-2000) mg/kg bw for males, and 1200 (900-1600) mg/kg bw for females. This may be explained by the use of the aqueous vehicle carboxymethyl cellulose at 1% in water compared to arachis oil used in the 1991 study.  As there was clear lethality in this validity 2 study, this will be used as the basis for the classification etc. The Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives was therefore classified in Category IV according to OECD-GHS.

 

There is a third study carried out in 1988 to an OECD 401 protocol, however this was testing of a polypropylene powder with 60% of the Ethanol, 2,2’-iminobis-, N-tallow alkyl derives using an aqueous vehicle with 0.5% carboxymethyl cellulose. In this study the LD50 was greater than the 2000mg/kg dose level used where no toxic effects were seen. It is not possible to know what impact the polypropylene powder had on this result other than reducing the exposure to the Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives. This study was therefore not considered suitable for classification etc. purposes.

 

Justification for classification or non-classification

As there was clear lethality in a validity 2 study, this will be used as the basis for the classification etc. The Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives was therefore classified in Category IV according to OECD-GHS. The lack of toxicity in the other validity 2 study may have been due to the use or arachis oil rather than a aqueous vehicle so it is considered appropriate to use the study showing the lethality.

There is no dermal LD 50 value as we have no data for acute skin toxicity of Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 but due to the corrosive nature of the substance it is not ethical to carry out this animal study. The corrosive classification of the Ethanol, 2, 2’-iminobis-, N-tallow alkyl derives 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

We also have no inhalation LC50 data for Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4, however it is a paste 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.

Due to the physical form of the Ethanol, 2,2’-iminobis-, N-tallow alkyl derives being a paste at ambient temperature, the is no aspiration hazard for this substance.