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Administrative data

Description of key information

Acute toxicity- oral: An oral LD50 of > 5000 mg/kg bw was determined in male/female Sprague-Dawley rats 14 days after treatment with propylene carbonate according to OECD Guideline 401. As acute oral LD50 rat is approximately 32319 mg/kg propylene carbonate may be considered as practically non-toxic after a single ingestion.
Acute toxicity- inhalation: No reliable studies were available for the inhalation route.
Acute toxicity- dermal: A dermal LD50 of > 2000 mg/kg bw was determined male/female New Zealand White rabbits 14 days after treatment with propylene carbonate according to OECD Guideline 402.
Acute toxicity- other routes: The LD50 values for single subcutaneous exposure were 15.8 mL/kg bw in mice and 11.1 mL/kg bw in rats after 72 hours of observation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute toxicity: oral

Pharmakon Research International, Inc. (1985) investigated the acute oral toxicity via gavage of 5000 mg/kg bw propylene carbonate in 10 Sprague-Dawley male/female rats. After 14 days of observation, no mortality has been observed and an LD50 of > 5000 mg/kg bw was reported. This study is designated as key study. In addition, BASF (1960) observed an acute oral LD50 of 32319 mg/kg bw in Schmitt-Fischer and Hanover male/female rats 7 days after treatment.

Acute toxicity: inhalation

No reliable studies were available for the inhalation route. A waiver statement was added and justified as following: next to the oral route of exposure, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route (REACH Regulation, column 2 adaptation of Annex VIII). For propylene carbonate, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed.

Acute toxicity: dermal

Mallory (1985) investigated acute dermal toxicity of propylene carbonate in 10 New Zealand White male/female rabbits after 24 hours of exposure. After 14 days of observation, an LD50 value of > 2000 mg/kg bw was reported. This study is designated as key study. In addition, Mallory (1986) observed an LD50 of > 3000 mg/kg bw in the same rabbit species under similar conditions.

Acute toxicity: other routes

Kuramoto (1972) investigated acute toxicity via the subcutaneous route of exposure (1 injection) in male mice and rats. The LD50 values after 72 hours of observation were 15.8 mL/kg bw in mice and 11.1 mL/kg bw in rats.

Justification for classification or non-classification

Based on the available data, propylene carbonate should not be classified for acute oral and acute dermal toxicity according to the criteria as specified in the CLP Regulation (EC) No 1272/2008. No data are available on the acute inhalation toxicity to decide on the classification for this route of exposure.