Registration Dossier

Administrative data

Description of key information

2, 1 and 3 valid studies with propylamine are available to assess the oral, dermal and inhalative LD50 for propylamine. The LD 50 were calculated as follows: LD50 oral: 370 mg/kg bw (rat), LD50 dermal: 403 mg/kg bw (rabbit), LC50 inhalation: 6.32 mg/l air (rat) 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
370 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
6 320 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
403 mg/kg bw

Additional information

Oral:

In a study which was in large part equivalent to methods described in OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 370 mg/kg body weight (BASF AG 77/500, 1978). Doses of 147, 215, 316, 464, 1000 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 14 days. Main clinical signs observed were dyspnoea, apathy, irregular respiration, staggering, spastic gait, ruffled fur. At necropsy, acute dilatation and congestion of the heart, slight acute lug distensions, strong diffuse erythema in the glandular stomach, strong erythema of the intestinal mucosa with and bloody diarrhetic content were observed. In an older publication the LD50 was calculated as 570 mg/kg bw (Smyth 1962). Thus, the most sensitive LD50 was established for propylamine.

 

Dermal:

In an older publication with rabbits, where only limited data on results are given, the acute dermal toxicity was 403 mg/kg bw (Smyth 1962).

 

Inhalation:

Acute inhalation toxicity of propylamine was analysed in a dynamic inhalation method study (BASF AG 77/500, 1978,). The mean LC50 after 4 h exposure and a subsequent 14 day recovery period was calculated as 7.06 mg/L air. The LC50 values for males and females were calculated as 6.32 and 7.87 mg/l. Main clinical signs observed were watery to reddish eyes and nose discharge, corrosions at nose and eyes, clouded cornea, salivation, dyspnoea, apathy, crouched position, rough and sticky coat, tremor and staggering walk. At necropsy, acute dilatation and congestion of the heart, infarctoic congestion of the lung partially accompanied by lung edema, effusion of blood in the thorax, mucosal bleeding in the cranial region, swelling of the anogenital region (except rectum) and cachexia were noted.

In a further study, rats were exposed to mist at concentrations of 400, 800, 1600 and 3200 ppm for 8 h. The calculated LC50 was 2310 ppm (Hine 1991). In spite of the rapid death of all rats at 3200 ppm, there was central degeneration of the liver and focal lymphocytic infiltration of the heart at the highest dose group. No macroscopically changes were seen at any dose group. Microscopically, central pallor of the liver and tubular degeneration of the kidney were seen.

Additional data were available from inhalation risk tests (IRT) which met generally accepted scientific principles (BASF AG 77/500, 1979). Rats were exposed to a saturated vapor-air mixture for 3 minutes. 11/12 animals died during or shortly after the 3 min inhalation period. Clinical signs were escape attempts, watery to bloody secretion of the nose, gasping for breath, cyanosis, corrosion at the nose, nebula, and ataxia. At necropsy, acute dilatation and congestion of the heart and acute distensions of the lung were noted.

Even though reliable, animals were exposed to mist rather than to vapour and no analytical verification of the doses was performed in the study of Hine (1991). Therefore, the LC50 value for acute inhalative toxicity was based on the dynamic inhalation method study (BASF AG 77/500). The LC50 value was set at 6.32 mg/l.

Justification for classification or non-classification

The available studies are considered reliable and suitable for classification purposes. According to Directive EC/1272/2008 the test substance is classified as harmful if swallowed (H302), toxic in contact with skin (H311) and toxic if inhaled (H331).

According to Directive 67/548/EEC the test substance is classified as harmful if swallowed (R22), harmful in contact with skin (R21) and harmful by inhalation (R22).