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Key value for chemical safety assessment

Effects on fertility

Description of key information

There is a new Oral (Gavage) reproduction/Developmental Toxicity Screening Test in the Rat (OECD 421) on Tallow bis(2-hydroxyethyl)amine oxide (CAS No 61791-46-6, Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides). The study is to the current guidelines and full GLP compliant.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch 1 study to OCED421 guidelines and with full GLP compliance.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Quality of whole database:
Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides has a low vapour pressure and is manufactured and sold as a paste 50% with 25% diethylene glycol and 25% water. Inhalation is therefore not an expected route of exposure. The ECHA guidance documents allow and inhalation DNEL to be calculated based on the oral repeat dose NOAEL, which will be done in this case.
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Quality of whole database:
Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides was not irritating to skin and only irritating to eyes, so any local effects would be limited to irritation. The ECHA Guidance document allows the calculation of dermal long tern DNELs based on the oral NOAEL. This is conservative approach as dermal absorption can be expected to be less than by the oral route. No testing is justified which avoid unnecessary use of additional animals.

Effects on developmental toxicity

Description of key information

There is a new Oral (Gavage) reproduction/Developmental Toxicity Screening Test in the Rat (OECD 421) on Tallow bis(2-hydroxyethyl)amine oxide (CAS No 61791-46-6, Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides). The study is to the current guidelines and full GLP compliant.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
150 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Klimisch 1 study to OCED421 guidelines and with full GLP compliance.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Quality of whole database:
Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides has a low vapour pressure and is manufactured and sold as a paste 50% with 25% diethylene glycol and 25% water. Inhalation is therefore not an expected route of exposure. The ECHA guidance documents allow and inhalation DNEL to be calculated based on the oral repeat dose NOAEL, which will be done in this case.
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Quality of whole database:
Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides was not irritating to skin and only irritating to eyes, so any local effects would be limited to irritation. The ECHA Guidance document allows the calculation of dermal long tern DNELs based on the oral NOAEL. This is conservative approach as dermal absorption can be expected to be less than by the oral route. No testing is justified which avoid unnecessary use of additional animals.

Mode of Action Analysis / Human Relevance Framework

In the OECD 421 study on Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides there were no adverse effects seen on any of reproductive parameters or on the development of the offspring. The top dose was 200mg/kg which proved too high and was reduced after 10 days to 150 mg/kg so it is certain that a maximum dose was administered so the lack of adverse effect is valid. Therefore there is no mode of action to discuss and no human relevant adverse effects were observed.

Justification for classification or non-classification

There were no adverse effects seen in the OECD 421 study on Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides on reproduction or development even at the top dose of 200 mg/kg bodyweight per day reduced after 10 days to 150 mg/kg bodyweight /day due to weight loss. This confirms that the top dose was a maximum tolerated dose so this study is valid and shows that there is no data to indicate that Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides produced any effects that would need a classification for toxicity to reproduction or development.

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