2-furaldehyde

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Record based on review performed by EPA "Furfural. Human health Risk assessment for Use on Golf Course Turf (Tees and Greens) and Sod Farms".

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Furfural. Human health Risk assessment for Use on Golf Course Turf (Tees and Greens) and Sod Farms

Author:

EPA

Year:

2010

Bibliographic source:

Office of prevention, Pesticides and Toxic Sustances, United States Environmental Protection Agency

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.3200 (Repeated Dose Dermal Toxicity -21/28 Days)

GLP compliance:

not specified

Limit test:

no

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

Constituent 2

Reference substance name:

furfural

IUPAC Name:

furfural

Details on test material:

- Name of test material (as cited in study report): technical liquid furfural
- Physical state: liquid
- Analytical purity: 94.48%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Remarks:

water applied to controls

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

28 days

Frequency of treatment:

6 hours/day, 5 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 25, 50, 100, 0, 100 mg/kg bw/day
Basis:
nominal per unit body weight

No. of animals per sex per dose:

10

Control animals:

yes

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to treatment and weekly thereafter

DERMAL IRRITATION (if dermal study): No data

BODY WEIGHT: Yes
- Time schedule for examinations: Weekly

FOOD CONSUMPTION:
- Food consumption : Yes

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to commencement of treatment and prior to sacrifice
- Dose groups that were examined: All animals

HAEMATOLOGY: Yes
- Time schedule for collection of blood: during the week prior to sacrifice
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: All animals

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: during the week prior to sacrifice
- Animals fasted: No data
- How many animals: All animals

URINALYSIS: Yes
- Time schedule for collection of urine: during the week prior to sacrifice
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data

NEUROBEHAVIOURAL EXAMINATION: No data

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Dermal irritation:

no effects observed

Mortality:

no mortality observed

Body weight and weight changes:

no effects observed

Ophthalmological findings:

no effects observed

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

no effects observed

Details on results:

Transient treatment-related effects in females at 100 mg/kg bw/day included drowsiness, dyspnea, clonic convulsion, hyperactivity, tremor. vocalisation. These were considered "not dose related or supported by weekliy observations made during the four week treatment or recovery periods."

Effect levels

Dose descriptor:

NOAEL

Effect level:

100 mg/kg bw/day (nominal)

Sex:

male/female

Basis for effect level:

other: no clear adverse effects on clinical signs, clinical pathology or histopathology at highest dose tested

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

In a 28-day repeated dose dermal toxicity study no evidence of systemic toxicity or dermal irritation were seen at doses up to 100 mg/kg bw/day.

Executive summary:

The EPA concluded "There were no clear cut adverse effects at the high dose level (100 mg/kg) which were supported by the results”. “An LOAEL was not achieved in this study" "Aluminium foil was used to enclose the furfural liquid on the dermal application site of the rat, this is not an acceptable method."