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EC number: 701-052-3 | CAS number: 146987-98-6
Endpoint summary
Administrative data
Description of key information
- LD50 >2000 mg/kg bw for males and >200 mg/kg bw <2000 mg/kg bw for females; orientation study; no guideline; RL2; no data on GLP
- LD50 (Males and Females combined) = 3478 (95% c.i. 3108 - 3878) mg/kg bw / LD50 (Males) = 3647 (95% c.i. 3114 - 4567) mg/kg bw / LD50 (Females) = 3317 (95% c.i. 2596 - 3853) mg/kg bw; OECD TG 401; RL1; GLP; read-across: Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl]
- LD50 < 1740 mg/kg bw (Males and Females combined); Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US), 1959; RL2; no GLP
Overall LD50 considered to be in the range of 300 and 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For the assessment of the acute toxicity of Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] an orientation study with the target substance itself is available. Two further acute toxicity studies conducted with the closely related source substance Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] are available. A justification for read-across is given in IUCLID section 13.
Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] was tested in an orientation study to determine the acute oral toxicity.
Therefore, two dosages (2000 mg/kg bw and 200 mg/kg bw) of the test substance were applied via gavage to 2-5 female and male Bor:WISW rats. Clinical signs were observed for a period of 14 days and gross pathology was conducted.
The 2000 mg/kg group shows 20% dead males and 80% dead females. Clinical signs are piloerection, reduced activity, heavy breathing, easily scared behaviour, wobbling motion, diarrhoea, red-braun fur in head area, semi closed eyes, whereas the 200 mg/kg bw group reveals no death or any other usual signs.
Therefore the LD50 was determined to be >2000 mg/kg bw for males and >200 mg/kg bw <2000 mg/kg bw for females.
In an acute oral toxicity study (standard acute method, according to OECD 401 (February, 1987) and the EEC directive 84/449 EEC), groups of 5 male and 5 female Wistar rats were given single oral doses of Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] in arachis oil and observed for 14 days.
Oral LD50 Males and Females combined after 14 days 3478 (3108 - 3878) mg/kg of body weight
Oral LD50 Males after 14 days: 3647 (3114 - 4567) mg/kg of body weight
Oral LD50 Females after 14 days: 3317 (2596 - 3853) mg/kg of body weight
The sample induced reduced activity (apathy), disturbance of coordination, reduced reflex excitability, cyanosis/paleness, piloerection, reduced body temperature and kachexia.
Post-dosing weight gains (2 week values) of the surviving animals did not show essential differences.
The mortalities showed residues of the sample in the digestive system and redness of the mucous membrane of the digestive system.
Nothing abnormal was found in the animals necropsied on day 14.
The test substance was judged to be practically non-toxic based on the oral LD50 in male and female rats.
In an acute oral toxicity study in accordance with the Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US) 1959, groups of fasted male and female young adult Wistar rats were given a single oral dose of Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] at doses of 2000, 2520, 3180, 3980 mg/kg bw and observed for 14 days. The substance was administered as 50% suspension in arachis oil warmed at about 37°C.
In the dose groups 2000, 2520, 3180, 3980 mg/kg bw 30, 50, 60, and 90 % of animals died after 24 hours, respectively. After 14 days 70, 80, and 100% of animals died, respectively. In the dose group 2000 and 2520 mg/kg bw animals were found dead between 24 h and 3 days. In the two highest dose groups animals were found dead on the first 24 or 48 hours after application.
No effects on body weight were observed. Decreased activity, reduced pain reaction, light tremor and twitches, obvious disturbance in coordination, abnormal body posture, decreased grip- and limp tone, diarrhea and piloerection were observed about 20 minutes after application and held on partly for 24 hours. Afterwards all animals showed a normal disposition. At doses from 2520 mg/kg bw upwards the animals showed in addition emaciated flanks and ptosis. Gross necropsies performed on the animals which died generally exhibited a redness of the gastrointestinal mucous membrane. Necropsies performed on the surviving animals at termination exhibited no gross pathological findings.
Oral LD50 Males/Females: < 2000 mg/kg bw.
No information on content of active ingredient of the test substance in the study report. However, according to producer information the test substance has 87% a.i., therefore the LD50 referring to 100% a.i. is < 1740 mg/kg bw.
In addition to the 14 d LD50, a 24 h LD50 (Males/Females) of 2570 (95 % CL 2350 - 2790) mg/kg bw was calculated for the product with 87 % a.i. (this value corresponds to a LD50 of approx. 2236 (95 % CL 2045 - 2427) mg/kg bw) for 100% a.i.).
The test substance Amides, C8-18 even numbered, N-[3-(dimethylamino)propyl] was judged to be slightly toxic based on the oral LD50 in male and female rats.
As no deaths, clinical signs or unusual findings in gross pathology were observed in the first orientation study at 200 mg/kg bw, the overall LD50 of Amides, C8 -18, C18 unsatd, N-[3-(dimethylamino)propyl] is considered to be in the range of 300 - 2000 mg/kg bw and thus is classified as Acute Toxicity Category 4.
Justification for selection of acute toxicity – oral endpoint
no single study was selected as key study, instead all avalaible data are considered together in a weight of evidence approach
Justification for classification or non-classification
Based on relevant, reliable and adequate data Amides, C8-18, C18 unsatd, N-[3-(dimethylamino)propyl] is classified as Acute toxicity Category 4, H302: Harmful if swallowed according to the CLP Regulation (EC) No 1272/2008.
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