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Registration Dossier
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EC number: 429-460-4 | CAS number: 7078-98-0
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:
- 1998-02-23 - 1998-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405) performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted on 24th Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-460-4
- EC Name:
- -
- Cas Number:
- 7078-98-0
- Molecular formula:
- C21 H26 O
- IUPAC Name:
- 2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, U.S.A. (on 2/24/98)
- Age at study initiation: bom the weeks of 12/07 through 12/21/97
- Weight at study initiation: 2.0 – 2.1 kg (females)
- Housing: 1/cage in suspended wire cages
- Diet: Fresh Purina Rabbit Chow, provided daily
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: temperature-controlled
- Humidity: Not indicated
- Photoperiod: 12 hours dark / 12 hours light
- Other: Room was kept clean and vermin free
IN-LIFE DATES: From: 1998-03-03 To: 1998-03-10
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 88 mg (0.1 mL equivalent) / rabbit - Duration of treatment / exposure:
- Continuous treatment. The treated eyes were not rinsed after the single instillation.
- Observation period (in vivo):
- 72 hours (assessment of eye reactions at 1, 24, 48 and 72 hour(s))
- Number of animals or in vitro replicates:
- 6 females
- Details on study design:
- TEST ITEM PREPARATION / TEST SITE
- 88 mg of the test item (0.1 mL equivalent) was placed into the conjunctival sac of one eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test item.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes were not rinsed after instillation.
SCORING SYSTEM: Numerical scoring system according to the numerical Draize technique
TOOL USED TO ASSESS SCORE: Mini-Maglite flashlight equipped with a high intensity bulb
OBSERVATIONS
- The general health of the animals was monitored at each observation time.
- Body weights were recorded pretest
- Necropsy: no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: pale areas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: pale areas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: pale areas
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.72
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- other: Conjunctiva: Discharge
- Basis:
- mean
- Remarks:
- (all animals)
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: observed in animal #1, #2, #5
- Irritant / corrosive response data:
- IRRITATION
Comeal opacity, noted in 1/6 eyes, cleared by 48 hours. Iritis, noted in 2/6 eyes, cleared by 24 hours. Conjunctival irritation, noted in 6/6 eyes, cleared by day 7. - Other effects:
- The fur around the eye stained yellow in case of all test animals
Any other information on results incl. tables
SYSTEMIC OBSERVATIONS
- There were no abnormal systemic observations.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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