Registration Dossier

Administrative data

Description of key information

There are two 90 day oral toxicity studies for Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 now to be registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6.  There is a 90 day dietary study in rats and a 90 Day study in dogs where the test substance was added to the diet in a solution in maize oil.  The Dog study was dosed at 13, 40, 120 mg/kg/day with a maize oil vehicle control.  The rats were feed diets containing 170, 500, 1’500 and 4’500ppm of the tests substance.  Both studies provide NOAEL values.  These studies were carried out in 1965, but are sufficiently well documented including information on the test substance to be considered suitable for use for REACH. Due to issues with sporadic vomiting and anorexia in the dog study, the data from the rat study will be used as the 90 day NOAEL.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
35 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

There are two 90 day oral toxicity studies for Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 now to be registered under

2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6. There is a 90 day dietary study in rats and a 90 Day study in dogs where the test substance was added to the diet in a solution in maize oil. The Dog study was dosed at 13, 40, 120 mg/kg/day with a maize oil vehicle control. The rats were feed diets containing 170, 500, 1’500 and 4’500ppm of the tests substance. Both studies provide NOAEL values. These studies were carried out in 1965, but are sufficiently well documented including information on the test substance to be considered suitable for use for REACH.

 

The 90 Day dog study, where the dogs were dosed by mixing a solution of the test substance in maize oil into the dry dog diet, suffered from serious problems with acceptance of the diet. This was due to corrosive/irritant nature of the test substance. The highest dose level of 120mg/kg/day vomited 2 to 3 hours after feeding and then began to refuse their food. Despite attempts to acclimatise them to the test substance this group had to be terminated after 5-6 weeks due to their poor condition, with 20% bodyweight loss. There was also sporadic vomiting and reluctance to eat all their food in the 40mg/kg/day group. This left the 13 mg/kg/day group as the NOAEL. In the 90 day rat study which some decrease in food consumption was evident at the higher dose levels the 500ppm in the diet level was a clear NOAEL. This was calculated to be ca. 35 mg/kg/day. Due to these problems with vomiting and reduced food consumption etc. in the dog study, the NOAEL from the rat study has been selected as being more reliable. This is supported by the findings of no clear systemic toxicity in either study, the effects seen in both studies be associated with local irritant effects in the gastrointestinal tract. The 35mg/kg/day NOAEL value will therefore be used for key value for the chemical safety report.

 

Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: ileum; digestive: jejunum

Justification for classification or non-classification

The toxic effects seen can be attributed to dietary administration with a corrosive test substance which caused damage/irritation due to the direct contact with the gastrointestinal tract. The no effect level in the rats was 35mg/kg/day, from the 90 day dietary study in rats was outside the range of 10-30 mg/kg/day where a classification as Category 2 for specific target organ toxicity after repeated exposure is required. Also the effects seen were not systemic such as serious organ damage but local effects in the gastrointestinal tract. As the only effects seen were none specific direct local effects of irritation and the NOAEL was above 30mg/kg/day, 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6 does not require classification for specific target organ toxicity.