Registration Dossier

Administrative data

Description of key information

Oral LD50: 1582 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
1 582 mg/kg bw

Additional information

γ-Butyrolactone is expected to exhibit a low degree of acute toxicity by all routes. Oral LD50 values of 1582 mg/kg bw (BASF, 1990) and 1920 mg/kg bw (GAF, 1952) have been reported for rats. For inhalation exposure, no mortality was observed in rats following a 4h exposure at 5.1 mg/L vapor and aerosol (Monsanto, 1986) and following an 8-hour exposure at saturated vapor concentrations of approximately 1 mg/L (at 20 °C) in air (BASF, 1960).

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Justification for classification or non-classification

Acute oral toxicity

Based on the results of acute oral toxicity testing (LD50 = 1582 mg/kg), gamma-butyrolactone is classified as Xn; R22 (Harmful if swallowed) under the EU DSD classification criteria (EU Directive 67/548/EEC). It is assigned an Acute Toxicity Category 4 rating (Harmful if swallowed) under the EU CLP classification criteria (EU Regulation 1272/2008).

Acute inhalation toxicity

Based on the presence of CNS effects, including drowsiness or dizziness in animal studies, gamma-butyrolactone is classified as R67 (Vapours may cause drowsiness and dizziness) under the EU DSD classification criteria (EU Directive 67/548/EEC). Gamma-butyrolactone would be rated STOT Single Exposure 3, based on CNS effects including drowsiness and or dizziness according to the EU CLP classification criteria (EU Regulation 1272/2008).

Acute dermal toxicity

Gamma-butyrolactone exhibits a low level of acute toxicity by the oral and inhalation routes of exposure. Furthermore, significant dermal absorption is not expected based up on physical chemical properties. An oral LD50 value of 1582 mg/kg-bw, combined with a measured dermal absorption of 1.1g/m2/hr, suggests that acute systemic toxicity via the dermal route is unlikely to occur under ordinary handling and use. Therefore, gamma-butyrolactone does not meet the criteria for classification under the EU DSD criteria (EU Directive 67/548/EEC) or under the EU CLP classification criteria (EU Regulation 1272/2008).