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Diss Factsheets

Administrative data

Description of key information

2 Ethylhexanal  is of low toxicity after a single ingestion, and virtually nontoxic after skin contact or inhalation exposure:
- oral: LD50: 2600 mg/kg bw (rat);
- inhalation: > 6.83 mg/L air (OECD 403);
- dermal: >16440 mg/kg bw (rat)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 600 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
6 830 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
16 640 mg/kg bw

Additional information

Oral:

In a study which was in large parts equivalent to methods described in OECD guideline 401, the LD50 for oral acute toxicity in rats was calculated as ca. 2600 mg/kg body weight (BASF AG, 1964; Val. 2). Doses of 164, 1315, 2630, 5261 mg/kg bw of an aqueous solution were applied by gavage followed by a post dose observation period of 7 days. Mortality was observed at doses >1315 mg/kg bw. Observed clinical signs were apathy and abdominal positions during exposure. After exposure (1 day p.a.) atonia, narcosis and again abdominal position were reported. No substance related effects were observed at necropsy. Survivors were without symptoms after 6 d.

 

In three further studies with only limited data provided, the test substance caused likewise slight toxicity after a single ingestion (LD50 = 3730 mg/kg bw; Smyth 1951; Val. 2; LD50 = 3550 mg/kg bw; Izmerov 1982; LD50>5000 mg/kg bw; Moreno et al. 1982; Val. 4).

 

Inhalation:

Acute inhalation toxicity was analyzed according to OECD guideline 403. After 4 h of exposure no mortality occurred and the LC50 was set to be over the applied dose of 6.83 mg/L air (BIBRA 1991; Val 1). During exposure the animals showed gradual reduction in respiratory rate combined with reduction to noise stimuli (most severe at 2 h of exposure). Additional irritations of the mucosa were observed and nostrils and eyes had reddish-brown colouration. At necropsy pale pink to deep-red colouration of the lungs (all animals), pale kidneys (2x males), opaque eyes with a small milky area (1x male) were noted.

 

Additional data were available from an inhalation risk test (IRT) which meets generally accepted scientific principles (BASF AG, 1963; Val. 2). The inhalation of 4.1 mg/L air for 8 h caused no mortality. Clinical signs were nasal discharge, closed eye lids and animals appeared anesthesised. In a publication were limited data is provided 25000 ppm (132 mg/l) for 13 min caused mortality in 3/3 animals. 4000 ppm (21 mg/l) for 4 h caused mortality in 1/6 animals. 2000 ppm (10 mg/l) for 23 min caused mortality in 3/3 animals.145 ppm (0.77 mg/l) for 6 h caused no mortality (Smyth et al. 1951; Val. 4).

 

Dermal:

Penetration of rabbit skin was estimated by a single limit dose of 20 ml/kg bw (calculated 16440 mg/kg bw) of the test substance, applied on 5 animals per sex for 24h. No mortality and no substance related clinical findings were reported within, besides erythema occurrence at the application site after termination of exposure. Erythema formation was reversible within 14 days. No signs of percutaneous adsorption were observed (Eastman Kodak, 1988; Val. 2).

Justification for classification or non-classification

No classification suggested for acute inhalative, dermal and oral toxicity as criteria of regulations 67/548/EC and 1272/2008/EC are not met.