Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours
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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.