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EC number: 601-643-5 | CAS number: 119959-84-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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
Test material
- Reference substance name:
- 4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
- EC Number:
- 601-643-5
- Cas Number:
- 119959-84-1
- Molecular formula:
- C21H16O6
- IUPAC Name:
- 4-(4-hydroxybenzoyloxy)-3-methylphenyl 4-hydroxybenzoate
- Details on test material:
- - Name of test material (as cited in study report): Bis-1,4-(p-Hydroxybenzoesaeure)-methylphenylendiester
- Physical state: solid
- Storage condition of test material: room temperature
- Analytical purity: 99.6% (HPLC)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG
- Age at study initiation: Young adult animals
- Weight at study initiation: 3.75 - 4.0 kg
- Housing: Single housing in stainless steel wire mesh cages with grating
- Diet: Kliba-Labordiaet, Provimi Kuba SA, Kaiseraugst, Switzerland ad libitum
- Water: Tap water ad libitum.
- Acclimation period: at least 1 week before study start
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 x 0.1 ml bulk volume (about 2 x 9 mg of the comminuted test substance) - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water
- Time after start of exposure: about 24 hours after application (before 24 hour reading).
SCORING SYSTEM: according to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Moderate erythema, slight swelling of the eye lids and slight discharge was 0 observed in all animals 1 hour after application. The conjunctival reactions were reversible in all animals within 72 hours after application at latest.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the described ocular reactions as well as the average score for irritation, the test substance does not give indication of an irritant property
to the eye under the conditions chosen. - Executive summary:
The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed in 3 White New Zealand rabbits. The animals were subjected to a double ocular application of 0.1 ml bulk volume (about 9 mg) of the test substance, corresponding to an amount of 18 mg administered. About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Moderate erythema, slight swelling of the eye lids and slight discharge was 0 observed in all animals 1 hour after application. The conjunctival reactions were reversible in all animals within 72 hours after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.0 for corneal opacity, for iris and for chemosis and 0.4 for conjunctival redness. Considering the described ocular reactions as well as the average score for irritation, the test substance does not give indication of an irritant property to the eye under the test conditions chosen.
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