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EC number: 485-140-4 | CAS number: 515815-48-2
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- Irritation / corrosion
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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:
- 24 January - 23 March 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC guidelines, see below).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 485-140-4
- EC Name:
- -
- Cas Number:
- 515815-48-2
- Molecular formula:
- C33 H30 N4 O2 x HCl
- IUPAC Name:
- 4’-(2-Propyl-4-methyl-6-(1-methylbenzimidazolyl-2-yl)-benzimidazol-1-ylmethyl)biphenyl-2-carbonsäure Hydrochlorid
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): BIBR 277 CL
- Molecular formula (if other than submission substance): C33H30N4O2*HCl
- Molecular weight (if other than submission substance): 514.6 + 36.5 g/mol
- Structural formula attached as image file (if other than submission substance): see reference substance
- Physical state: solid; sligh grey
- Analytical purity: 99.8 %
- Purity test date: 17. october 2005
- Lot/batch No.: 9
- Expiration date of the lot/batch: april 2006
- Storage condition of test material: at room temperature, dark and dry
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ferenc Sandor breeder, Kartal, Hungary
- Age at study initiation: young adult rabbits, 10 weeks old
- Weight at study initiation: from 2940 to 34 18 g
- Housing: housed individually in metal cages
- Diet (e.g. ad libitum): Puristar rabbit diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 24 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 8-12 per hour
- Photoperiod (hrs dark / hrs light): 12 hrs each
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A total volume of 0.1g of the test item was used for the study in pure state, in a single dose. The test item was instilled into the conjunctival sac of the left eye of each animal. The eyelids were held closed gently for several seconds to prevent the loss of the test item. The contralateral eye served as control. The eyes of the test animals were not washed out after test item application.
- Duration of treatment / exposure:
- 72 hours (single dose)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after start of the treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
The eye irritation scored were evaulated according to the scoring system by Draize (1959) and OECD 405 ( 24 April 2002).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
One hour after treatment in all animals the vessels were more diffuse (score 2), with obvious conjunctival swelling with partial eversion of the lids (score 2) and the discharge with moistening of the lids and hairs on considerable area around the were found (score 3). In these animals diffuse areas of opacity were observed on the cornea involved was greater than three quarters, up to the whole area (score 4). Iris alterations were not recorded throughout the study period.
24 hours after treatment in one animal some hyperaemic blood vessels occurred (score 1). Chemosis and increased discharge excretion were not found by this time. In two animals the degree and extension of cornea opacity did not change when compared to the previous observation (score 1, 4). One animal was free of irritation symptoms at 24 hours after the treatment.
48 hours after the treatment irritation of conjunctivae was not found in the treated animals. In two animals the degree and extension of cornea opacity did not change when compared to the previous observation (1, 4).
72 hours after treatment all animals were free of irritation symptoms.
72 hours after treatment the study was terminated, with animals free of symptoms of irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- BIBR 277 CL, applied to the rabbit's eye mucosa caused conjunctival and corneal irritant effects, fully reversible within 72 hours. According to EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
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