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EC number: 689-734-6 | CAS number: 39903-01-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 02 to 30 Aug 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study run to a method comparable with current guidelines and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-amino-5-bromopyridin-3-ol
- EC Number:
- 689-734-6
- Cas Number:
- 39903-01-0
- Molecular formula:
- C5H5BrN2O
- IUPAC Name:
- 2-amino-5-bromopyridin-3-ol
- Details on test material:
- - Purity: 96.2% w/w
- Batch No.: CCS-952/STG-02/00109
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France and Harlan, Belton, Leics, England
- Age at study initiation: Between 10-20 weeks old
- Weight at study initiation: 2-4 kg
- Housing: Labeled cages with perforated floors and shelters
- Diet (e.g. ad libitum): Pelleted diet approximately 100 grams per day, hay was provided at least three times a week
- Water (e.g. ad libitum): Free access to tap water
- Acclimation period: At least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0±3.0℃ (actual range: 19.0-20.0℃)
- Humidity (%): 40-70% (actual range: 50-87%)
- Air changes (per hr): Approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours darkness per day
IN-LIFE DATES: From: 2010-08-02 To: 2010-08-30
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 66.9 mg (range 66.5-67.3 mg) - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner three weeks later, after considering the degree of eye irritation observed in the first animal.
Treatment:
Animals were treated by instillation of, on average, 66.9 mg (range 66.5 - 67.3 mg) of the test substance (a volume of approximately 0.1 mL), in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Immediately after the 24-hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. Any bright green stained area, indicating epithelial damage, was estimated as a percentage of the total corneal area.
After the final observation, the animals were sacrificed by intra-venous injection of Euthasol® 20%.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Fully reversible within 48 hours in one animal and within 7 days in the other two animals.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48 and 72 hours
- Score:
- ca. 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Fully reversible within 48 hours in all of 3 animals.
- Irritant / corrosive response data:
- No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
There was no evidence of ocular corrosion. - Other effects:
- No staining of (peri) ocular tissues by the test substance was observed. Remnants of the test substance were present in the eyes of two animals on Day 1.
No symptoms of systemic toxicity were observed in the animals during test period and no mortality occurred.
Any other information on results incl. tables
Individual eye irritation scores
Animal |
Time after dosing
|
Cornea (0-4) |
Iris (0-2) |
Conjunctivae |
||
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
||||
452 |
1 hour 24 hours 48 hours 72 hours |
0 0 0 0 |
0 0 0 0 |
1 1 0 0 |
1 1 0 0 |
1 1 0 0 |
482 |
1 hour 24 hours 48 hours 72 hours 7 days |
0 0 0 0 0 |
0 0 0 0 0 |
2 2 1 1 0 |
2 1 0 0 0 |
1 1 0 0 0 |
483 |
1 hour 24 hours 48 hours 72 hours 7 days |
0 0 0 0 0 |
0 0 0 0 0 |
2 2 1 1 0 |
1 1 0 0 0 |
1 1 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No eye irritation was caused by exposure to the test substance.
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