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EC number: 200-838-9 | CAS number: 75-09-2
The available oral and dermal LD50 values and the calculated 4-h inhalation LC50 value of DCM are all above the classification cut-offs. In rats, administration of 2000 mg/kg bw did not induce mortality, either via the oral or the dermal route. In the mouse, an inhalation 7-hour LC50 value of 49000 mg/m3 has been reported which was recalculated into a 4-h LC50 value of 86000 mg/m3 taking Haber’s rule into account.
The oral and dermal LD50 values and the inhalation LC50 values indicate that the acute toxicity of dichloromethane is low.
Table 1. The acute toxicity of vapours of dichloromethane for mice.
Concentration in air
Number of fatalities following exposure
The acute toxicity of dichloromethane by inhalation, oral and dermal administration is low.
Based on animal studies, DCM does not need to be classified for acute toxicity for any route of exposure. LD50 values of > 2000 mg/kg bw were determined in an oral and dermal toxicity study with rats (guideline studies). In a well-documented publication a 7 -h LC50 of 49 mg/Lair was determined in mice; based on Haber’s rule, this corresponds to a 4 -h LC50 value of 86 mg/L. Although the observation period was only one day, it was noted that only one more animal died between 8 and 24 h. Based on the clinical signs noted, an acute effect rather than a long-term effect seemed to have been present, and as such no delayed mortality is expected. As such a 4-h LC50 value of 86 mg/L is far above the classification limit of 20 mg/L, and therefore no classification is needed for acute inhalation toxicity.
With regard to non-lethal toxicity, adverse effects were observed in humans (case and experimental studies).The principal effects were effects on visual-manual tasks and carbon monoxide intoxication. The effects on visual-manual tasks became apparent at lower concentrations than those causing carbon monoxide intoxication. The lowest LOAEC observed (see 7.10.3) was equal to 200 ppm (0.706 mg/L) for a 4 -h exposure. Decreased tracking performance and a decline in the response time in the visual-peripheral component of dual tasking were observed. In this study no NOAEC was obtained but in another study (see 7.10.2), systemic effects in humans exposed to 100 ppm (0.353 mg/L) for 8 h/day for a period of three days were not observed. Based on possible short-term pre-narcotic effects, the SCOEL recommends a STEL (15 min) of 200 ppm (0.706 mg/L). This value will be used as DNEL for acute inhalation exposure.
Justification for selection of acute toxicity – oral endpoint
OECD Guideline 401 and GLP-compliant study
Justification for selection of acute toxicity – inhalation endpoint
Acceptable, well-documented publication, predates OECD guidelines and GLP, minor restrictions in design and reporting, but otherwise adequate for assessment
Justification for selection of acute toxicity – dermal endpoint
Although application area was rather small, this was not considered to have significantly influenced the outcome of the study; OECD Guideline 402 and GLP-compliant study
On the basis of the observed CNS effects in human studies, dichloromethane should be regarded as a substance which produces vapours that may cause drowsiness and dizziness (R67) according to Directive 67/548/EEC. According to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the substance should be classified as STOT - Single exposure Cat 3; H336.
Based on the oral and dermal LD50 and inhalation LC50 values, classification for acute toxicity is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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