Registration Dossier
Registration Dossier
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EC number: 202-627-7 | CAS number: 98-01-1
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
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:
- 2 010
- Bibliographic source:
- Office of prevention, Pesticides and Toxic Sustances, United States Environmental Protection Agency
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- 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
- 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
- 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%
Constituent 1
Constituent 2
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."
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