Registration Dossier
Registration Dossier
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EC number: 207-434-1 | CAS number: 471-01-2
Endpoint summary
Administrative data
Description of key information
The acute toxicity in laboratory animals is low to moderate (oral LD50 ≥ 1500 mg/kg bw; dermal LD50 ≥ 1200 mg/kg bw; inhalative LC50 = 7000 mg/m3).
Key value for chemical safety assessment
Additional information
Oral toxicity
LD50 values of isophorone in rats were 1500 mg/kg bw (Günzel and Richter, 1968a), 2100 mg/kg bw (Dutertre-Catella, 1976) and 3450 mg/kg bw (Esso Research, 1964) The LD50 in mice is 2200 mg/kg bw (Dutertre-Catella, 1976). Clinical signs like general apathy, depression, weariness (leading to coma) ptosis, lacrimation and laboured respiration occurred at doses of ≥ 1450 mg/kg bw (Günzel and Richter, 1968a, Dutertre-Catella, 1976, Esso Research, 1965b). At doses of ≥ 5000 mg/kg bw congestion of lungs, kidneys and pancreas (Esso Research, 1964) and liver lesions (Dutertre-Catella, 1976) were found at necropsy.
Inhalation toxicity
In acute inhalation studies isophorone showed very low acute toxicity with LC50 values sometimes exceeding the maximum tested concentrations (> 3500 and = 7000 mg isophorone/m3) in rats, mice and guinea pigs (Esso Research 1964, Esso Research, 1965b). Mortality was observed in another study with rats but not guinea pigs at concentrations ≥ 10,570 mg/m3 (Smyth and Seaton, 1940). Clinical signs were nose and eye irritation, accelerated, laboured respiration, intestinal peristalsis and coma at dose ≥ 5000 mg/m3 (Smyth and Seaton, 1940, Esso Research, 1965b). At necropsy of the high exposure concentrations, congestion of the lungs and occasionally observed liver and stomach congestion was found (Esso Research, 1965b; Smyth and Seaton, 1940).
Dermal toxicity
In rats, the LD50 after dermal application was 1700 mg/kg bw (Günzel and Richter, 1968b). For rabbits the LD50 values were 1200 mg/kg bw (Dutertre-Catella, 1976) and > 3160 mg/kg bw (Esso Research, 1964). Clinical signs were general apathy, later on occasionally coma, cachexia, tremor, lacrimation (Günzel and Richter, 1968b) and depression, accelerated/labored respiration, sprawling, prostration and narcosis at doses of 3160 mg/kg bw at least. At necropsy uniform thickening of the cutaneous stomach mucosa and pulmonary emphysema, edema or hyperemia was observed.
Justification for classification or non-classification
Based on the results of the acute toxicity studies, isophorone should be classified with Xn, R20/21/22 according to Directive 67/548/EEC. According to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 it should be classified for acute oral and dermal toxicity as Acute tox 4, H302 and H312, and for acute inhalation toxicity as Category 3, H331.
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