Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-627-7 | CAS number: 98-01-1
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- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment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:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- 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
- 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.
Constituent 1
Constituent 2
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:
- 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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- 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
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
