Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated

Carcinogenicity

Description of key information

The absence of neoplastic lesions or carcinogenic activity in two 2-yr chronic bioassays in rodents suggests that the structural homologue tested (please refer to ch. 13 for justification) and consequently the target substance is not considered to have carcinogenic potential. 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Carcinogenicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Exceeds the information requirements for this tonnage band.

Justification for classification or non-classification

The absence of neoplastic lesions or carcinogenic activity in chronic bioassay in rodents suggests that amides, C18 -unsatd., N, N-bis(hydroxyethyl) is not considered to have carcinogenic potential. Therefore based on the overall weight of evidence, amides C18 -unsatd., N, N-bis(hydroxyethyl), does not require classification for the carcinogenicity endpoint according to EC criteria (67/548/EEC) and CLP criteria (EC 1272/2008).

Additional information

Two year chronic dermal studies (NTP report 481, 1999) have been conducted with the close homologue oleic acid diethanolamine condensate (ODEA) in rats and mice and have been thouroughly investigated as part of the US National Toxicology Programme (NTP).

 

F344/N rats were administered doses of 0, 50, or 100 mg/kg bw/d of the test substance to 50 male and female test animals in each group. Five exposures per week were given for 104 weeks.The mean body weights of males and females (week 24 onwards) were reduced than those of the vehicle control group at 100 mg/kg bw/day. Dose dependent increase in irritation (i.e., mild to moderate) and non-neoplastic lesions (i.e., minimal to moderate) of the skin was observed at the site of application in males and females. The non-neoplastic lesions included epidermal hyperplasia, sebaceous gland hyperplasia, hyperkeratosis, parakeratosis, chronic active dermal inflammation, and ulcer. No significant neoplastic lesions or evidence of carcinogenic activity was observed at any tested dose levels in skin, testis and thyroid gland.

Under the test conditions, no evidence of carcinogenic activity was observed with the test substance at any tested dose levels in rats. The NOAEL for systemic effects and the LOAEL for local effects can be considered to be at 50 mg/kg bw/d respectively.

B6C3F1 micewere administered doses of 0, 15 or 30 mg/kg bw/d to 50 male/female test animals in each group. 5 exposures per week were given for 105 weeks.5 males and 5 females were considered for the 3-month interim evaluation mice. The mean body weights of females (week 76 onwards) were reduced than those of the vehicle control group at 30 mg/kg bw/day. The only significant treatment related clinical finding was irritation of the skin at the site of application in 30 mg/kg bw/day males. The incidences of epidermal hyperplasia, sebaceous gland hyperplasia, and chronic active inflammation of the dermis in all dosed groups were significantly increased relative to the vehicle controls at 3 months and at 2 years. The increased incidences of hyperkeratosis in dosed males at 3 months and in dosed males and females at 2 years, of parakeratosis in 30 mg/kg bw/day males at 3 months and 2 years, and of ulcer in 30 mg/kg bw/day males and exudate in 30 mg/kg bw/day males and females at 2 years were also attributed to the test substance administration. No significant neoplastic lesions or evidence of carcinogenic activity was observed at any tested dose levels in skin and lymph nodes. Under the test conditions, no evidence of carcinogenic activity was observed with the test substance at any tested dose levels in mice. The NOAEL for systemic and local effects can be considered to be at 15 mg/kg bw/d respectively (NTP 481 report, 1999).

Justification for selection of carcinogenicity via dermal route endpoint:
2 year dermal rat study conducted by NTP and appropriate to base the assessment on.