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Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
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, restrictions in design and / or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Study protocol based on Shelby MD, Erexson GL, Hook GJ and Tice RR (1993). Evaluation of a three-exposure mouse bone marrow micronucleus protocol: Results with 49 chemicals. Environ. Mol. Mutagen. 21, 160-179.

GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
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:
2-Furancarbinol; 2-furanmethanol; furfuralcohol;α-furylcarbinol; 2-furylcarbinol; 2-hydroxymethylfuran
IUPAC Name:
2-Furancarbinol; 2-furanmethanol; furfuralcohol;α-furylcarbinol; 2-furylcarbinol; 2-hydroxymethylfuran
Details on test material:
- Name of test material (as cited in study report): Furfuryl alcohol
- Physical state: Not reported
- Analytical purity: Not reported
- Lot/batch No.: Not reported

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS: No details reported
ENVIRONMENTAL CONDITIONS: No details reported
IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: phosphate-buffered saline
Duration of treatment / exposure:
3 days
Frequency of treatment:
once daily at 24 hour intervals (3 injections in total)
Post exposure period:
24 hours after 3rd injection
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 15.625, 31.25, 62.5, 125, 250 mg/kg
Basis:
nominal conc.
No. of animals per sex per dose:
5 males
Control animals:
yes, concurrent vehicle
Positive control(s):
cyclophosphamide
- Route of administration: Intraperitoneal injection
- Doses / concentrations: 15 mg/kg

Examinations

Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION: Not reported

TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): Mice were injected intraperitoneally three times at 24-hour intervals with furfuryl alcohol dissolved in phosphate-buffered saline; the total dosing volume was 0.4 mL. Solvent control animals were injected with 0.4 mL of phosphate-buffered saline only. The positive control animals received injections of cyclophosphamide. The mice were killed 24 hours after the third injection

DETAILS OF SLIDE PREPARATION: Smears were prepared from bone marrow cells obtained from the femurs. Air-dried smears were fixed and stained

METHOD OF ANALYSIS: 2,000 polychromatic erythrocytes (PCEs) were scored for the frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.
Evaluation criteria:
2000 polychromatic erythrocytes (PCEs) were scored for the frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity. An individual trial is considered positive if the trend test P value is less than or equal to 0.025 or if the P value for any single dose group is less than or equal to 0.025 divided by the number of dose groups. A final call of positive for micronucleus induction is preferably based on reproducibly positive trials.
Statistics:
The frequency of micronucleated cells among PCEs was analysed by a statistical software package that tested for increasing trend over dose groups with a one-tailed Cochran-Armitage trend test, followed by pairwise comparisons between each dosed group and the control group (Margolin et al., 1990). In the presence of excess binomial variation, as detected by a binomial dispersion test, the binomial variance of the Cochran-Armitage test was adjusted upward in proportion to the excess variation.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
At a dose level of 250 mg/kg, all of the mice died.

Any other information on results incl. tables

Dose (mg/kg)

Micronucleated PCEs/1000 PCEs

Pairwise P values

PCEs (%)

0 (vehicle control)

1.00±0.16

 

53.22±2.68

15.625

1.50±0.69

0.159

55.22±2.03

31.25

1.00±0.32

0.500

58.74±4.04

62.5

1.40±0.56

0.207

59.18±2.11

125

1.40±0.19

0.207

52.98±3.34

250

all mice died

 

 

 

 

15 (positive control – cyclophosphamide)

8.80±1.34

0.000

48.04±2.56

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
There was no induction of micronuclei noted in bone marrow cells of male B6C3F1 mice after administration of furfuryl alcohol by intraperitoneal injection.
Executive summary:

Male B6C3F1 mice were injected intraperitoneally three times at 24-hour intervals with furfuryl alcohol dissolved in phosphate-buffered saline; the total dosing volume was 0.4 mL. Vehicle control animals were injected with 0.4 mL of phosphate-buffered saline only. The positive control animals received injections of cyclophosphamide. The mice were killed 24 hours after the third injection, and smears were prepared from bone marrow cells obtained from the femurs. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were scored for the frequency of micronucleated cells in each of five animals per dose group. In addition, the percentage of PCEs among the total erythrocyte population in the bone marrow was scored for each dose group as a measure of toxicity.

 

There was no induction of micronuclei noted in bone marrow cells of male B6C3F1 mice after administration of furfuryl alcohol by intraperitoneal injection.