2-furaldehyde

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study with some restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

NTP Technical report on the the toxicology and carcinogenesis studies of furfural (CAS NO. 98-01-1) in F344/N rats and B6C3F1 mice (gavage studies)

Author:

Irwin R

Year:

1990

Bibliographic source:

NIH publication No. 90-2837. National Toxicology Program, Research Triangle Park, North Carolina 27709, USA

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

13 week study to evaluate the cumulative toxic effects of repeated administration of furfural and to determine the doses to be used in 2 year study. The publication also includes 16 day and 2 year studies. Only the 13 week study is reported in this summary and only the results relating to the reproductive organs are discussed. The data from the two year assay are not considered relevant for potential reproductive effects given the age of the animals at the time of evaluation.

GLP compliance:

no

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

2-furaldehyde

EC Number:

202-627-7

EC Name:

2-furaldehyde

Cas Number:

98-01-1

Molecular formula:

C5H4O2

IUPAC Name:

2-furaldehyde

Details on test material:

- Lot no.: Q112979
- Source: Quaker Oats Co., Chicago, IL, USA
- Appearance: Clear, yellow liquid
- Purity: 99%

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY, USA
- Age at study initiation: 8-9 weeks
- Housing: 5 animals/polycarbonate cage
- Diet (ad libitum): NIH07 Rat and Mouse Ration (Ziegler Bros., Inc., Gardners, PA, USA
- Water (ad libitum): automatic
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 72-76
- Humidity (%): 34-60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: 22 Jan 1981 - 27 April 1981

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

No data reported

Duration of treatment / exposure:

5 days/week for 13 weeks

Frequency of treatment:

once daily

Duration of test:

13 weeks

Doses / concentrations

Remarks:

Doses / Concentrations:
75, 150, 300, 600 and 1200 mg/kg bw/day
Basis:
nominal conc.

No. of animals per sex per dose:

10

Control animals:

yes, concurrent vehicle

Details on study design:

Organ weights obtained at necropsy. The following tissues examined histologically for all controls and mice receiving 300, 600 or 1200 mg/kg/day: adrenal glands, brain, colon, esophagus, eyes (if grossly abnormal), femur or sternebrae or vertebrae including marrow, gall bladder, gross lesions and tissue masses with regional lymph nodes, heart, kidneys, liver, lungs and mainstem bronchi, mammary gland, mandibular or mesenteric lymph nodes, nasal passage and turbinates, pancreas, parathyroid glands, pituitary gland, preputial gland, prostate/testes or ovaries/uterus, salivary glands, small intestine, spinal cord (if neurologic signs present), spleen, stomach, thymus, thyroid gland, trachea, and urinary bladder.

Statistics:

No details

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

300 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no reported effects on the weight or histology of the reproductive organs at this lethal dose

Observed effects

The dose levels of 600 and 1200 mg/kg/day were lethal for the mouse. No effects on the weights or histology of the reproductive organs were reported at 300 mg/kg/day, a dose level that produced lower body weights and increased liver weight and liver histopathology.

Applicant's summary and conclusion

Conclusions:

13 weeks of oral administration of furfural at 300 mg/kg/day caused reduced body weight and increased liver weight in mice but no effects on the weights or histology of any of the reproductive organs were reported.

Executive summary:

The purpose of this 13 week study was to evaluate the cumulative toxic effects of repeated administration of furfural and to determine the doses to be used in a 2 year mouse study. The data from the two year assay are not considered relevant for potential reproductive effects given the age of the animals at the time of evaluation.

In the 13 week study, the dose levels of 600 and 1200 mg/kg/day were lethal to the mice. 300 mg/kg/day caused reduced body weight and increased liver weight but no effects on the weights or histology of any of the reproductive organs were reported.