2-furaldehyde

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 July 2004 to 11 August 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

stability & characterisation of test substance not reported

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

as above

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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 technical
- Substance type: Technical
- Physical state: Yellow liquid
- Analytical purity: 99.64%
- Purity test date: Not reported
- Lot/batch No.: DT 623-20/05/2004
- Expiration date of the lot/batch: May 20, 2005
- Stability under test conditions: Expected to be stable for the duration of testing.
- Storage condition of test material: Stored at room temperature in dark / refrigerated in the dark after opening.
- Other: Specific gravity 1.163 g/mL

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals Inc., Boyertown, PA, USA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 387-445g (males), 210-264g (females)
- Fasting period before study: no
- Housing: single housed in suspended stainless steel cages with mesh floors and litter paper beneath the cage.
- Diet : Purina Rodent Chow # 5012
- Water : Tap water ad libitum.
- Acclimation period: 5 or 13 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21-24°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 20 July 2004 To: 11 August 2004

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Dorsal area and the trunk
- % coverage: approximately 10% of the body surface
- Type of wrap if used: 2 inch x 3 inch 4-ply gauze pad wrapped with 3-inch Durapore tape
- The use of Elizabethan collars prevented oral contamination

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test area cleansed of residual test substance
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: and 0.066 - 0.071 mL (males) and 0.036 - 0.040 (females) for 200 mg/kg, 0.71-0.77 mL (males) and 0.39 - 0.45 mL (females) for 2000 mg/kg
- Concentration: 100% (dosed as supplied)
- Constant volume or concentration used: no - dose volume adjusted for body weight and specific gravity

Duration of exposure:

24 h

Doses:

200 and 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed frequently after dosing and then daily thereafter. Weighed prior to dosing and then on days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

Not appropriate (no mortalities)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no deaths

Mortality:

There were no deaths following exposure to 200 or 2000 mg/kg furfural technical.

Clinical signs:

other: At 2000 mg/kg signs of dermal irritation (erythema and oedema) were noted at the dose site of most animals between Days 1 and 3. There were no adverse clinical signs in animals exposed to 200 or 2000 mg/kg furfural technical and all animals survived to

Gross pathology:

There were no gross abnormalities in animals exposed to 200 or 2000 mg/kg furfural technical.

Applicant's summary and conclusion

Conclusions:

The acute dermal LD50 of furfural technical in male and female rats was greater than 2000 mg/kg.

Executive summary:

In an acute dermal toxicity study, 200 or 2000 mg/kg of furfural technical was applied to the skin of two groups of 5 male and 5 female rats for 24 hours. Following exposure to 2000 mg/kg, signs of skin irritation (erythema and oedema) were observed at the dose site of most animals between Days 1 and 3. There were no deaths and no adverse clinical signs of toxicity. All animals survived to scheduled termination on day 14 and there were no gross abnormalities at necropsy. The acute dermal LD50 of furfural technical in male and female rats was considered to be greater than 2000 mg/kg.