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Diss Factsheets

Administrative data

Description of key information

Two repeated dose dermal toxicity studies (14-days and 28-days) in rabbits are available for phenoxypropanol. Both studies have been conduced under GLP and are equivalent or similar to OECD guideline 410. For the oral route 3 GLP-studies according to OECD guidelines 407, 408 and 416 have been conducted in rats using drinking water administration of the test material.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
146 mg/kg bw/day
Study duration:

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day
Study duration:

Additional information

Oral: In a 90-day drinking water study in rats concentrations of 500, 2000 and 6000 ppm have been used. At 500 ppm no substance related effects have been observed and at 2000 ppm the only effects observed were decreased body weight (less than 10%) and discoloration of urine. Therefore, the 2000 ppm (146 mg/kg bw/d) dose level is considered to be the NOAEL and will be used as critical dose descriptor to derive the DNEL.

This data is supported by the results of a 2 -generation reproductive toxicity study in rats and the 4 week range finder for this study, both conducted via drinking water administration of the test material. PPh was administered to two generations of rats (25/sex/group) in for 26 weeks at concentrations of 100, 1000, or 5000 ppm (equivalent to doses of 0, 11.3, 113, or 478 mg/kg-d) (this study is also discussed in section 7.8.1). Effects were seen only at the highest exposure concentration that manifested as reduced body weights and corresponding reduced food and water consumption. No clinical signs were evident during the course of exposure and no gross or histopathological lesions were seen at autopsy. The NOEL for this drinking water study with rats was 1000 ppm (113 mg/kg-d) and the LOAEL was 5000 ppm (478 mg/kg-day), based on body weight changes.

Dermal: two GLP-studies in rabbits are available for the dermal route of exposure. In a 28 -day study no systemic effects have been observed up to the limit dose of 1000 mg/kg bw/day. Mild dermal irritation characterized by slight hyperemia and moderate exfoliation was observed in the 1000 mg/kg/day animals. Slight exfoliation was observed in most of the 300 mg/kg/day animals (slight hyperemia was also present for females), while 100 mg/kg/day animals showed only very slight exfoliation. Therefore, the NOAEL for local effects is 100 mg/kg bw/day. This is supported by a 14 -day study where no systemic effects have been observed at the limit dose of 1000 mg/kg bw/day, but dermal irritation was evident at this dose level.

Inhalation: no studies via the inhalation route are available for PPh. However, based on the low vapor pressure of this material inhalation exposure is not considered to be relevant.

Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys

Justification for classification or non-classification

The no observed adverse effect levels for phenoxypropanol exceed the values triggering classification. Therefore no classification for prolonged exposure is required.