Furfuryl alcohol

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP status unknown, no guidelines mentioned, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1986

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Test method as reported by Mortelmans et al (1986). Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat liver or Syrian hamster liver). Following incubation with L-histidine and d-biotin supplemented agar, histidine –independent mutant (revertant) colonies were counted.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Furfuryl alcohol

EC Number:

202-626-1

EC Name:

Furfuryl alcohol

Cas Number:

98-00-0

Molecular formula:

C5H6O2

IUPAC Name:

(furan-2-yl)methanol

Constituent 2

Reference substance name:

Furfruyl alcohol

IUPAC Name:

Furfruyl alcohol

Details on test material:

- Name of test material (as cited in study report): Furfuryl alcohol
- Analytical purity: 98.6%
- Other: Supplied by Quaker Oats

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

- Type and identity of media: Columbia agar and Columbia broth
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no
- Periodically checked for karyotype stability: yes/no
- Periodically "cleansed" against high spontaneous background: yes/no

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced male Sprague-Dawley rat liver S9 and cofactor mix.

Test concentrations with justification for top dose:

100, 333, 1000, 3333, 10000 µg per plate
33 µg per plate was also used in 1 trial with TA1537.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

yes

Remarks:

Potassium chloride

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation

Migrated to IUCLID6: (TA1535 and TA100)

Controls 2

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine (TA98)

Remarks:

without metabolic activation

Controls 3

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation

Migrated to IUCLID6: (TA1537)

Controls 4

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

(all strains with metabolic activation).

Details on test system and experimental conditions:

Furfuryl alcohol was incubated with the Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37°C. Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37°C.

Each trial consisted of triplicate plates of concurrent positive and negative controls and five doses of furfuryl alcohol. The high dose was limited by experimental design to 10,000 μg/plate. All trials were repeated.

Evaluation criteria:

In this assay, a positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity. A negative response is obtained when no increase in revertant colonies is observed following chemical treatment. There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Furfuryl alcohol (33-10,000 μg/plate) was not mutagenic in Salmonella typhimurium strain TA98, TA100, TA1535, or TA1537, with or without S9 metabolic activation enzymes.

Executive summary:

Fufuryl alcohol was tested in a Salmonella mutagenicity test (bacterial reverse mutation test) and was incubated with the Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver). Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37°C. Each trial consisted of triplicate plates of concurrent positive and negative controls and five doses of furfuryl alcohol.

Furfuryl alcohol was not mutagenic in Salmonella typhimurium strain TA98, TA100, TA1535, or TA1537, with or without S9 metabolic activation enzymes, at concentrations of 33 - 10000 μg/plate.