Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 695-977-9 | CAS number: 1309955-79-0
There are no repeat dose studies on Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs. But there are two 90 day oral toxicity studies for the read across substance Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 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.
A NOEL of 500 ppm in the diet corresponds with:
ca. 33 mg/kg bw in males (taking into account a mean food intake of 20 g/day and a mean BW of 300 g throughout the study period)
ca. 35 mg/kg bw in females (taking into account a mean food intake of 15 g/day and a mean BW of 200 g throughout the study period)
The test substance Ethomeen T/12 was administered via the diet daily for 90 days to Wistar rats. One control group and four treated groups were tested, each consisting of 25 males and 25 females (except for the high dose group that had 10 animals per sex). These were exposed to 0, 170, 500, 1500 or 4500 ppm. A further group of 14 rats, 7 males and 7 females, was fed a diet containing 4500 ppm Ethomeen T/12 end killed at intervals up to 6 weeks from the beginning of the experiment. Tissues from these animals were examined for sudanophilic material.
The following parameters were evaluated: clinical signs, body weight and food consumption, haematology, and macroscopy at termination, organ weights and histopathology on a selection of tissues.
No deaths occurred prematurely and males and females responded similarly. At the highest dose level hairloss was observed and the animals were generally lethargic throughout the experiment. At the other dose levels no effects were noted. Body weights: At 4500 ppm, no body weight gain was observed and at 1500 ppm a decreased body weight gain was observed. At lower levels no effects were observed. Food consumption: The palatability of the diet was affected by the addition of 4500 and 1500 ppm test compound. Haematology: No effects were noted. Pathology: Changes attributed to treatment were seen only in animals at a dietary level of 4500 ppm. These changes were confined to the gastrointestinal tract. The stomach and bowel content of all rats at this dietary level was yellow and the mucooa of the small intestine was thickened and yellow. The mean organ body-weight ratios were not different from controls. Abnormality was seen only at a dietary level of 4,500 ppm and 1,500 pppm and was confined to the small intestine and regional mesenteric nodes. All animals fed 4,500 ppm in the diet showed engorgement of the villi and lamina propria of the small intestine with swollen foamy macrophages. Similar macrophages are occasionally seen to a lesser degree in Peyer's patches and in the regional lymph nodes. Changes were most proounced In the jejunum and upper ileum but could be detected throughout the small intestine. The macrophages were sudanophilic and were presumed to contain deposits of Ethomeen T/12. The other components of the intestinal wall appeared completely normal. A similar change was present to a lesser degree in 31 of 40 rats fed a dietary level of 1,500 ppm. No changes were present ot a dietary level of 500 ppm or less of Ethomeen T/12.
From this study a NOEL of 500 ppm can be derived. At higher levels animals did not gain weight normally and showed pathological changes confined to the small intestines and its regional lymph nodes. This dietary level corresponds to ca. 35 mg/kg bw/day.
There are no repeat dose studies on Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs. But there are two 90 day oral toxicity studies for the read across substance Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 registered under2,2’-(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 as Klimisch 2.
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 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 for read across to Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The rat study was selected as the dose level in the dog study was less clear. The read across to this substance is justified in the document attached in Section 13.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
Inhalation is not an expected route of exposure due to the low vapour pressure of the substnace and its corrocive properties to skin would make it vety technically difficult to perform.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Due the test substance being considered to be corrosive to skin based on the read across substance, it is not possible to conduct repeat dose dermal toxicity studies due to animal welfare considerations. Data from the repeat dose oral studies can be used in the setting of DNELs.
Justification for selection of repeated dose toxicity dermal - local effects endpoint:
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: ileum; digestive: jejunum
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again