2-furaldehyde

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 July 2002- 15 August 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to OECD principles of GLP and based on OECD no. 401 (1987), available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

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): Furfural
- Physical state: clear yellow liquid
- Analytical purity: >99%
- Lot/batch No.: FF 280302
- Expiration date of the lot/batch: March 28, 2003
- Storage condition of test material: stored in the original container as supplied by the sponsor (i.e. glass bottle) at room temperature.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding facility, Jai Research Foundation
- Age at study initiation: 9-11 weeks at time of dosing
- Weight at study initiation: 199-264 g (males) and 151-194 g (females)
- Fasting period before study: minimum 17 hours and 15 minutes
- Housing: 5 animals of the same sex
- Diet: Rat pellet diet (Amrut brand) (Pranav Agro Industries Ltd., Pune, Maharashtra, India ad libitum (except for the pre-dose fast and for approximately 3 hours after dosing)
- Water: Filtered drinking water ad libitum
- Acclimation period: minimum of 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature: 19-24°C
- Humidity: 64-66%
- Air changes: 25/hour
- Photoperiod: 12 hours dark, 12 hours light

IN-LIFE DATES: From: 30 July 2002 To: 15 August 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 7, 10, 12, 14, 20.5 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

70, 100, 120, 140, 205 mg/kg

No. of animals per sex per dose:

10 animals per sex per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examined for mortality and morbidity 1, 2 and 3 hours and once thereafter on the day of dosing, and at least twice per day thereafter. Clinical signs were recorded daily and body weights weekly (days 0, 7 and 14).
- Necropsy of survivors performed: yes

Statistics:

Acute oral LD50 calculated using the probit analysis (Finney DJ, 1971, Probit Analysis, 3rd edition, Cambridge University Press p.333)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

100 mg/kg bw

Based on:

test mat.

95% CL:

63 - 159

Remarks on result:

other: 5/10 mortalities at 100 mg/kg

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

105 mg/kg bw

Based on:

test mat.

95% CL:

88 - 125

Remarks on result:

other: 4/10 mortalities at 100 mg/kg, 6/10 mortalities at 120 mg/kg

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

108 mg/kg bw

Based on:

test mat.

95% CL:

97 - 121

Mortality:

mortality at dose levels
0: males 0/10 females 0/10
70: males 0/10 females 2/10
100: males 5/10 females 4/10
120: males 6/10 females 6/10
140: males 7/10 females 8/10
205: males 10/10 females 10/10

Clinical signs:

other: Lethargy, tremors, abdominal breathing, tachypnea, exophthalmos, piloerection in some treated animals. Bronchial rales were observed in the 100 and 140 mg/kg dose group. Lethargy was observed in all the treated animals at all dose levels during the 1 h ob

Gross pathology:

External examination of "found dead" animals revealed froth from nostrils. Terminally sacrificed animals did not reveal any lesion of pathological significance. Visceral examination of "found dead"animals showed prominent lesions in lungs (congestion/ haemorrhage, oedema, consolidation, emphysema); liver (mottling / haemorrhage) and intestine (mucus exudation). These lesions could be considered as test substance related. Terminally sacrificed animals revealed various inflammatory / vascular changes with low level of occurrence which could be considered as spontaneous / incidental findings and unrelated to test substance.

Applicant's summary and conclusion

Conclusions:

In an acute oral toxicity study in rats, LD50 values of 100, 105 and 108 mg/kg bw/day were established for male rats, female rats and combined sexes, respectively.

Executive summary:

In an acute oral toxicity study in rats, to modern guidelines, acute oral LD50 values of 100, 105 and 108 mg/kg bw/day were established for male rats, female rats and combined sexes, respectively.