2-furaldehyde

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 February - 11 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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye 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 liquid
- Analytical purity: 99.62%
- Lot/batch No.: 5371
- Expiration date of the lot/batch: October 10, 2003
- Storage condition of test material: Stored in original container as supplied by the sponsor (i.e. glass bottle), at room temperature.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: JRF Breeding facility
- Weight at study initiation: 2.48 - 2.54 kg
- Housing: Individually housed in stainless steel wire mesh cages (45.7 x 60.0 x 45.7 cm)
- Diet: Rabbit pellet diet (Amrut brand) (Pranav Agro Industries Limited, Pune, Maharashtra, India) ad libitum.
- Water: Filtered drinking water ad libitum
- Acclimation period: 6 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: 25 February 2003 To: 11 March 2003

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: 0.1 mL distilled water instilled into other eye in the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted test substance

Duration of treatment / exposure:

treated and control eyes were washed with distilled water after 24 hours post-treatment

Observation period (in vivo):

14 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 24 hours post treatment with distilled water
SCORING SYSTEM: according to OECD (1987) and US EPA (1998)
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.9

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: fully reversible within 72 hours for 2 animals

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

conjunctival redness

Basis:

mean

Time point:

24/48/72 h

Score:

2.1

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.56

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Corneal opacity and conjunctival redness and chemosis was present in all 3 rabbits. There was no iridial involvement. All signs of eye irritation had cleared in all 3 rabbits 14 days after instillation.

Any other information on results incl. tables

Table 1: Eye irritation scores of Furfural according to the Draize scheme

Time		Cornea			Iris			Conjunctiva
								Redness			Chemosis
	Animal number	1	2	3	1	2	3	1	2	3	1	2	3
after 1 hour		0	1	1	0	0	0	2	2	2	1	1	1
after 24 hours		1	1	1	0	0	0	2	3	3	1	3	3
after 48 hours		1	1	2	0	0	0	2	2	3	1	2	1
after 72 hours		0	0	1	0	0	0	1	1	2	1	1	1
mean scores 24-72 hours		0.7	0.7	1.3	0	0	0	1.7	2.0	2.7	1.0	2.0	1.7
after 7 days		0	0	1	0	0	0	1	1	1	1	1	1
after 14 days		0	0	0	0	0	0	0	0	0	0	0	0

 

No eye irritation was seen in the control eyes.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Based on an eye irritation study in rabbits, Furfural is classified as "Irritating to eyes" Category 2.