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Description of key information

There are two reliable acute oral toxicity studies availble. The most critical LD50 is 1740 mg/kg bw according to a.i.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 740 mg/kg bw

Additional information

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  the substance 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.

At doses of 2000, 2520, 3180, 3980 mg/kg bw 30, 50, 60, 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 within the first 24 and 48 hours after application. 

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 (14 days) Males/females: 2000 mg/kg bw.

No information on content of active ingredient of the test substance was given in the study report. However, according to producer information substance the 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 substance 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 the substance was judged to be slightly toxic based on the oral LD50 (14 days) in male and female rats.

In an acute oral toxity 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 the substance in arachis oil and observed for 14 days.

Oral LD50 Males and Females combined after 14 days: 3478 (3208-3878) 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 test animals showed 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 FETTSĂ„UREDIMETHYLAMINOPROPYLAMID was judged to be practically non-toxic based on the oral LD50 in male and female rats.

Both studies have been performed under comparable conditions (concentrations doses, test animal species, vehicle etc.) the substance under investigation induced similar clinical sings. However, in the acute oral toxicity study in accordance with the Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US) 1959 the substance under investigation was classified as slightly toxic (no data to analytical purity were reported, however substance used as delivered by the sponsor; according to producer information the substance has 87 % a.i.). In the acute oral toxity study (standard acute method, according to OECD 401 (February, 1987) and the EEC directive 84/449 EEC), test substance (no data to analytical purity were reported) was judged to be practically non-toxic. The acute oral toxicity study in accordance with the Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US) 1959 is a valid well-performed test; in terms of hazard precaution the LD50 1740 mg/kg was selected as the most appropriate.

Justification for classification or non-classification

Both studies were performed under comparable conditions (concentrations doses, test animal species, vehicle etc.), the substance under investigation induced similar clinical signs. However, in the acute oral toxicity study in accordance with the Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US) 1959 the substance under investigation was classified as slightly toxic (no data to analytical purity were reported, however substance used as delivered by the sponsor; according to producer information the substance has 87 % a.i.). In the acute oral toxity study (standard acute method, according to OECD 401 (February, 1987) and the EEC directive 84/449 EEC), test substance (no data to analytical purity were reported) was judged to be practically non-toxic. The acute oral toxicity study in accordance with the Appraisal of the safety of chemicals in foods, drugs and cosmetics, by FDA (US) 1959 is a valid well-performed test; in terms of hazard precaution the LD50 1740 mg/kg was selected as the most appropriate value.

The test substance has to be classified as harmfull acording to Directive 67/548/EEC and in Acute Toxicity Category 4 according to GHS Regulation EC No 1272/2008.

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