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EC number: 214-772-3 | CAS number: 1193-24-4
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-09-25 to 1995-10-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 6-hydroxy-1-H-pyrimidin-4-one
- IUPAC Name:
- 6-hydroxy-1-H-pyrimidin-4-one
- Reference substance name:
- 4,6-dihydroxypyrimidine
- IUPAC Name:
- 4,6-dihydroxypyrimidine
- Reference substance name:
- 6-hydroxy-1H-pyrimidin-4-one
- EC Number:
- 214-772-3
- EC Name:
- 6-hydroxy-1H-pyrimidin-4-one
- Cas Number:
- 1193-24-4
- Molecular formula:
- C4H4N2O2
- IUPAC Name:
- 6-hydroxypyrimidin-4(3H)-one
- Details on test material:
- - Substance type: pure active substance
- Physical state: solid, homogeneous brownish-yellow powder
- Analytical purity: 99.8 area-% HPLC
- Impurities (identity and concentrations): water 1.78%
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain HsdPoc:NZW
- Age at study initiation: adult
- Weight at study initiation: 2.9 - 3.1 kg
- Housing: conventional, individual animals in stainless steel cages
- Diet: ad libitum, Ssniff R 10 Alleindiaet fuer Kaninchen
- Water: communal drinking water ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 1995-09-25 To: 1995-10-02
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g finely ground solid test substance placed into the conjunctival sac of one eye
- Untreated eye serves as control
VEHICLE
- none - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 6 days
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with warm physiological saline
- Time after start of exposure: 24 hours after application (after fluorescein test) and 48 hours after application
SCORING SYSTEM: OECD Guideline 405: Table 1: Grading of ocular lesions
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any time point
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any time point
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no changes at any time point
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- no changes at any timepoint
- Irritant / corrosive response data:
- One hour after the application of the test material, distinct hyperemia of some blood vessels (score 1) and slight chemosis (score 1) were observed in all animals. 24 hours later, one animal was free of irritation symptoms, two still showed hyperemia of some blood vessels (score 1), one of them in combination with slight chemosis. After 48 hours, the erythema was unchanged (score 1) in these two animals, whereas the chemosis had disappeared. After 72 hours, the erythema was only detected in one animal. On day 6, all animals had no more signs of irritation of the eyes or mucosae. No changes of the iris and cornea were detected throughout the observation period.
- Other effects:
- White slimy exudate in 2/3 animals 1 h after treatment.
Any other information on results incl. tables
Individual results:
| Time post application | 1 h | 24 h | 48 h | 72 h | 6 d | ||||||||||
| Animal | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
| Conjunctivae: erythema | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | - | - |
| Conjunctivae: chemosis | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - |
| Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - |
| Examination w. fluorescein | - | - | - | 0 | 0 | 0 | - | - | - | - | - | - | - | - | - |
| Exudation (white, slimy) | x | x |
From the numerical scores of the individual animals at 24, 48, and 72 hours, the following averages were calculated:
Animal 1 |
Animal 2 |
Animal 3 |
Average |
|
Conjunctivae: erythema |
1.00 |
0 |
0.67 |
0.56 |
Conjunctivae: chemosis |
0.33 |
0 |
0 |
0.11 |
Iris |
0 |
0 |
0 |
0 |
Cornea |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is considered to be slightly irritating. The study is considered to be relevant and reliable.
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