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Toxicological information

Repeated dose toxicity: dermal

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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

Referenceopen allclose all

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 Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.3200 (Repeated Dose Dermal Toxicity -21/28 Days)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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."