Amides, tall-oil fatty, N-[3-(dimethylamino)propyl]

Endpoint summary

Description of key information

In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

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

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was administered daily to groups of Wistar rats (5/sex/dose) at doses of 0 (vehicle), 10, 50 and 150 mg/kg bw/day over a period of 28 days by gavage. Examinations during the study included: mortality, clinical signs, functional observation battery (including motor activity), body weight change, food and water consumption, ophthalmological examinations, hematology, blood chemistry, urinalysis, organ weights, macroscopic examination and histopathology.

No deaths occurred during the study and only slight signs of toxicity were observed at 150 mg/kg bw/day: salivation was observed in all male and female animals on few days between Day 11 and 28, and respiration sounds were observed after treatment in 3 male animals and 4 female animals on several days between Day 7 and 28. These findings were assessed as adverse and related to the test article in the study report. However, it is considered by expert judgement that these sporadic and transient effects are not adverse and probably due to an unpleasant taste of the substance as often observed with chemical compounds. This hypothesis is also considered by the authors of the report of the OECD 421 study (Reproduction/Developmental toxicity screening test) in which same findings are observed without increased incidence or frequency at dose-levels up to 200 mg/kg/day. No significant treatment-related changes were noted in the body weight gain, food and water consumption, ophthalmological examinations, hematological parameters, urinalysis and neurotoxicological parameters at any dose-level. No treatment-related effects were noted on organ weights or necropsy and microscopic findings.

Under the test conditions, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in the male and female Wistar rats by expert judgement (stated 50 mg/kg bw/day in the study report).

Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Well performed study according to OECD 407 guideline and under GLP protocol.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
No repeated dose toxicity study via inhalation is available. N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) is a liquid with a vapour pressure around 1.78 10-7 Pa at 25°C (EPI suite estimation). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no subacute inhalation test is needed.

Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
Exposure via inhalation is unlikely.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
The substance is corrosive for skin. Therefore, dermal route is not the preferred route for repeated dose toxicity studies.

Justification for selection of repeated dose toxicity dermal - local effects endpoint:
The substance is corrosive for skin. Therefore, dermal route is not the preferred route for repeated dose toxicity studies.

Justification for classification or non-classification

Based on the available results (Kaspers 2009) and according to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC (DSD), the substance is not classified for repeated dose toxicity.