2-furaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 February 2003-10 March 2003

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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 appearance: colourless to dark brown
- Analytical purity: 99.62%
- Lot/batch No.: 5371
- Expiration date of the lot/batch: 10 October 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:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: JRF Breeding Facility
- Weight at study initiation: 2.40-2.85 kg
- Housing: Individually housed in stainless steel wire mesh cages (45.7 x 60.9 x 45.7 cm)
- Diet: Rabbit pellet diet (Amrut brand) ad libitum (Pranav Agro Industries Limited, Maharashta, India)
- Water: Filtered drinking water ad libitum
- Acclimation period: 5 days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature: 18-23°C
- Humidity: 62-66%
- Air changes: 19 air changes per hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From:24 February 2003 To 10 March 2003

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: concurrent control site on the same animal

Amount / concentration applied:

0.5 mL furfural

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: gauze patch (manufactured by Kohinoor Product, India) and gauze dressing not more then 8-ply, which was secured by Medi tape 330 hypo-allergenic surgical tape (JMS, Japan) to prevent evaporation of the test substance.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed with cotton soaked in distilled water
- Time after start of exposure:4 hours

SCORING SYSTEM: Draize method (Draize JH, Woodward G, Calvery HO, 1944. J. Pharmacol. Exp. Ther., 82: 377-390).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

erythema in all three animals up to day 7 (grades 1, 2 or 3)
oedema in two animals up to 72 hours (grade 1)

Any other information on results incl. tables

Table 1: Individual and mean skin irritation scores of Furfural according to the Draize scheme

Time	Erythema			Oedema
Animal number	1	2	3	1	2	3
after 1 hour	3	2	2	0	0	0
after 24 hours	3	2	2	1	0	1
after 48 hours	2	2	2	1	0	1
after 72 hours	2	1	2	1	0	1
mean score 24-72 hours	2.3	1.7	2.0	1.0	0	1.0
after 7 days	1	1	1	0	0	0
after 14 days	0	0	0	0	0	0

 

There was no erythema or oedema at the control sites.

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Furfural is mildly irritating to rabbit skin

Executive summary:

In a skin irritation study in rabbits, based on the observed mean scores following grading at 24, 48, and 72 hours after exposure to the test material, Furfural is classified according to the Harmonised Integrated Classification System for Human Health and Environmental Hazards of Chemical Substances and Mixtures (ENV/JM/MON) (2001)6, No.33, OECD as "mildly irritating to skin" Category 3.