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Diss Factsheets

Administrative data

Description of key information

Subchronic inhalation toxicity studies with furfuryl alcohol in rats and mice and a subchronic dietary toxicity study in rats with the proximate metabolite, furfural, are available. Evidence of slight systemic toxicity was seen following oral exposure whilst following inhalation exposure the primary effect is irritation leading to tissue damage in the nasal region with a reported LOAEC of 2 ppm (8 mg/mg3).  In the context of establishing a DNEL the adversity of the effect is further discussed under Section 5.8 and 5.11.2 of the CSR.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
53 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

Via the oral route, no substantive data are available for furfuryl alcohol. Based on comparable absorption, distribution, metabolism and excretion of furfural and furfuryl alcohol it is appropriate to consider data for the proximate metabolite, furfural, for systemic toxicity. The toxicity of furfural was reviewed and a final Risk Assessment Report published by the EU in 2008 (EU RAR, 2008). The key study identified for oral toxicity was a 13 week feeding study in rats (Jonker, 2000a,b). No new studies have been identified and there are no newly published studies on the oral toxicity of furfuryl alcohol. For furfuryl alcohol inhalation exposure, where the LOAECs are associated with local rather than systemic effects, the key studies are considered to be 14-week inhalation studies in rats and mice conducted as preliminaries to carcinogenicity studies by NTP (NTP, 1999).

In a 13 -week oral toxicity study rats were exposed to the proximate metabolite, furfural, via their feed. Haematological differences and minor microscopic liver changes were seen in males at 82 and 160 mg/kg. In females minor clinical chemistry changes were seen at 170 mg/kg (Jonker, 2000a,b). There is reference to an unpublished 13-week oral toxicity study with furfuryl alcohol in NTP (1999). In this study mild hepatic and renal effects were reported at 75, 150 and 300 mg/kg/day with a NOAEL of 38 mg/kg/day. The overall oral NOAEL is from the Jonker (2000a,b) study and is 53 mg/kg bw/day

In the key 14-week (5 days/week, 6 hours/day) inhalation toxicity studies in rats and mice the only evidence of systemic toxicity induced by furfuryl alcohol was lower body weight gain in female rats at 32 ppm (128 mg/m3), the highest dose tested (NTP, 1999). However, local changes were observed in the nasal passages of both sexes in both species at all concentrations tested. The findings indicate that furfuryl alcohol causes significant irritation and tissue damage. The reported LOAEC for local effects was 2 ppm (equivalent to 8 mg/m3). The adversity of the nasal irritation effects are discussed further under Section 7.7 of IUCLID and of Section 5.8 the CSR.

The NOAEC for systemic effects was 16 ppm (equivalent to 64 mg/m3) in the rat and 32 ppm (equivalent to 128 mg/m3) in the mouse.

Justification for classification or non-classification

Following repeated oral or inhalation exposure there was no evidence of significant target organ toxicity at dose level below regulatory thresholds and no classification is warranted for this end-point. The local effects (due to respiratory (nasal tissue) irritation) are covered by the respective classification (Xi, R37 under DSD and STOT-SE H335 under CLP).

However, furfuryl alcohol has been classified under DSD as R48 (as included in the 31st ATP of Dir 67/548/EEC) and in Annex VI as CLP Cat 2 STOT-RE H373* ("May cause damage through prolonged or repeated exposure”) and this classification will be applied, even though it is considered not to be warranted after assessment of the available data.