Registration Dossier

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Administrative data

Description of key information

Non-GLP studies equivalent or similar to OECD guidelines 401 and 402 as well as GLP-studies according to OECD guidelines 402 and 403 are available for phenoxypropanol.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 830 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
5 400 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Oral: two non-GLP studies equivalent to OECD guideline 401 have been conducted with phenoxypropanol in rats. Both studies report LD50 greater than 2000 mg/kg bw/day.

Dermal: in a GLP-study according to OECD guideline 402 the dermal LD50 of phenoxypropanol in rats was greater than 2000 mg/kg bw. This data is supported by a non-GLP study similar to OECD guideline 402 which reports a dermal LD50 greater than 2000 mg/kg bw in rabbits.

Inhalation: in a GLP-study according to OECD guideline 403 the LC50 of phenoxypropanol (liquid aerosol) was greater than 5.4 mg/L (highest concentration tested). No mortality was observed in this study.

Justification for classification or non-classification

LD50 values for oral and dermal route are greater than 2000 mg/kg/bw and no mortality has been observed after inhalation exposure to phenoxypropanol up to the highest dose tested. According to the EU criteria for classification and labeling, phenoxypropanol is not classified for acute toxicity for any route of exposure.

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