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Toxicological information

Eye irritation

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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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye 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 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

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: fully reversible within 72 hours for 2 animals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
conjunctival redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.1
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on an eye irritation study in rabbits, Furfural is classified as "Irritating to eyes" Category 2.