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Administrative data

Description of key information

Subacute repeated oral toxicity study was performed to determine the oral toxic nature of 2-Furoic acid upon repeated exposure for 14 days. The study was performed using male Sprague Dawley rats. The test chemical was dissolved in 1% CMC and used at dose levels of 0 or 20 mg/Kg/day.On day 7 and 14, the animals were bled between 7:30-8:30 a.m. Serum Cholesterol and triglycerides were determined. The animals were sacrificed on day 14. 2-Furoic acid at 20 mg/kg/day orally suppressed the serum cholesterol levels 50% and serum triglyceride levels 42% after 14 days in rats. The HDL cholesterol content was elevated 34% on day 14. The VLDL and LDL cholesterol levels were not reduced at this dose. Based on the data available, the No Observed adverse effect level (NOAEL) for 2-Furoic acid is considered to be 20 mg/Kg bw.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed publication
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Subacute repeated oral toxicity study was performed to determine the oral toxic nature of 2-Furoic acid upon repeated exposure for 14 days
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of test material: 2-furoic acid
- IUPAC name: 2-Furancarboxylic Acid
- Molecular formula : C5H4O3
- Molecular weight: 112.084 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data
Species:
rat
Strain:
Sprague-Dawley
Details on species / strain selection:
No data
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: ≈ 300-350 g approx.
- Fasting period before study: No data
- Housing: The animals were placed in plastic cages
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22˚C
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle

IN-LIFE DATES: From: To: No data
Route of administration:
oral: gavage
Details on route of administration:
No data
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1%
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: 2-Furoic acid was dissolved in 1% CMC at dose levels of 0 or 20 mg/Kg/day

DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data

VEHICLE
- Justification for use and choice of vehicle (if other than water): % CMC
- Concentration in vehicle: 0 or 20 mg/Kg/day
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
14 days
Frequency of treatment:
Daily
Remarks:
0 or 20 mg/Kg/day
No. of animals per sex per dose:
N: 6
Control animals:
yes, concurrent vehicle
Details on study design:
No data
Positive control:
No data
Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data

DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data

BODY WEIGHT: Yes
- Time schedule for examinations: Periodic animal weights were obtained during the experiments and expressed as % of the animal’s weight on day 0

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes, daily
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data

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 AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data

OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data

HAEMATOLOGY: No data
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On day 7 and day 14
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Serum cholesterol and triglycerides

URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data

NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data

OTHER: No data
Sacrifice and pathology:
GROSS PATHOLOGY: Yes, the animals were sacrificed on day 14. Selected organs were excised, trimmed of fat, and weighed

HISTOPATHOLOGY: No data
Other examinations:
No data
Statistics:
No data
Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Description (incidence and severity):
No detailed data available
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
Food consumption for control group was 19.39 g/day and for the treated group it was 16.35 g/day. A 15.8% reduction in food consumption/day was noted.
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
2-Furoic acid at 20 mg/kg/day orally suppressed the serum cholesterol levels 50% and serum triglyceride levels 42% after 14 days in rats. The HDL cholesterol content was elevated 34% on day 14. The VLDL and LDL cholesterol levels were not reduced at this dose.
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Description (incidence and severity):
No detailed data available
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
No data
Dose descriptor:
NOAEL
Effect level:
20 other: mg/Kg bw
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No significant alterations were noted at the mentioned dose level
Critical effects observed:
not specified

Table 1: Effects of 2-Furoic Acid on Serum Lipid and Lipoprotein Cholesterol Levels of Sprague Dawley Rats after 14 Days Administration at 20 mg/kg/Day Orally

N: 6

Serum Cholesterol

Lipids

triglycerides

Lipoprotein cholesterol content

VLDL

LDL

HDL

Control

100±7a

100±6b

100±6c

100±6d

100±6e

Treated

50±5*

58±6*

112±7

100±7

134±7*

a 78 mg/dL

b 112 mg/dL

c 190µg/mL       

d 210µg/mL

e 544µg/mL

* P≤0.001 Student’s “t” test

Conclusions:
The No Observed adverse effect level (NOAEL) for 2-Furoic acid is considered to be 20 mg/Kg bw.
Executive summary:

Subacute repeated oral toxicity study was performed to determine the oral toxic nature of 2-Furoic acid upon repeated exposure for 14 days. The study was performed using male Sprague Dawley rats. The test chemical was dissolved in 1% CMC and used at dose levels of 0 or 20 mg/Kg/day.On day 7 and 14, the animals were bled between 7:30-8:30 a.m. Serum Cholesterol and triglycerides were determined. The animals were sacrificed on day 14. 2-Furoic acid at 20 mg/kg/day orally suppressed the serum cholesterol levels 50% and serum triglyceride levels 42% after 14 days in rats. The HDL cholesterol content was elevated 34% on day 14. The VLDL and LDL cholesterol levels were not reduced at this dose. Based on the data available, the No Observed adverse effect level (NOAEL) for 2-Furoic acid is considered to be 20 mg/Kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
20 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Data is from K2 peer reviewed publication

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity: Oral

Data available for the target chemical was reviewed to determine the repeated dose oral toxic nature of 2 -Furoic acid. The study is as mentioned below:

Subacute repeated oral toxicity study was performed by Hall et al (Arch. Pharm. (Weinheim) (1993)) to determine the oral toxic nature of 2-Furoic acid upon repeated exposure for 14 days. The study was performed using male Sprague Dawley rats. The test chemical was dissolved in 1% CMC and used at dose levels of 0 or 20 mg/Kg/day.On day 7 and 14, the animals were bled between 7:30-8:30 a.m. Serum Cholesterol and triglycerides were determined. The animals were sacrificed on day 14. 2-Furoic acid at 20 mg/kg/day orally suppressed the serum cholesterol levels 50% and serum triglyceride levels 42% after 14 days in rats. The HDL cholesterol content was elevated 34% on day 14. The VLDL and LDL cholesterol levels were not reduced at this dose. Based on the data available, the No Observed adverse effect level (NOAEL) for 2-Furoic acid is considered to be 20 mg/Kg bw.

Based on the data available for the target chemical, 2 -Furoic acid is not likely to classify as a toxicant upon repeated exposure by oral route.

Justification for classification or non-classification

Based on the data available for the target chemical, 2 -Furoic acid (CAS no 88 -14 -2) is not likely to classify as a toxicant upon repeated exposure by oral route.