Registration Dossier
Registration Dossier
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EC number: 217-568-2 | CAS number: 1889-67-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1993-02-24 to 1993-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,1'-(1,1,2,2-tetramethylethylene)dibenzene
- EC Number:
- 217-568-2
- EC Name:
- 1,1'-(1,1,2,2-tetramethylethylene)dibenzene
- Cas Number:
- 1889-67-4
- Molecular formula:
- C18H22
- IUPAC Name:
- (2,3-dimethyl-3-phenylbutan-2-yl)benzene
- Test material form:
- solid: flakes
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 12 weeks
- Weight at study initiation: 2689 - 2993 g
- Housing: Individually in labelled cages with perforated floors and equipped with an automatic drinking system.
- Diet: Standard laboratory rabbit diet (LKK-20, peller diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water: Free access to tap-water diluted with decalcified water.
- Acclimation period: at least five days before start of treatment under test conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as reference control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 64 ± 1 mg per animal - Duration of treatment / exposure:
- single treatment for 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- SCORING SYSTEM: according to EU and OECD guidelines (Draize system)
TOOL USED TO ASSESS SCORE: fluorescein, pocket flash light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Instillation of the test substance into one eye of each of the three male albino rabbits affected the conjunctivae. The irritation of the conjunctivae had resolved within 48 h in one animal and within 72 h after instillation in the two other animals. Treatment of the eyes with 2% fluorescein, 24 h after test substance instillation revealed no corneal epithelial damage in any of the animals.
There was no evidence of ocular corrosion. - Other effects:
- No staining of per-ocular tissues by the test substance was observed. No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1,1'-(1,1,2,2-tetramethylethylene)dibenzene resulted in a slight conjunctivae redness which was reversible within at least 72 h (mean score 24/48/72 h: 0.33 - 0.67), when applied to the rabbits eye. No adverse effects were observed for parameters cornea, iris and discharge (score 0 in all animals).
- Executive summary:
The eye irritation potential of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was assessed according to OECD guideline 405 and EU method B.5. The test item was instilled into one eye of each of three male albino rabbits (New Zealand White), followed by four observations at approximately 1, 24, 48 and 72 h after test substance administration. Under the conditions of the study, 1,1'-(1,1,2,2-tetramethylethylene)dibenzene resulted in adverse effects on the conjunctivae in all three animals, which had resolved within 48 - 72 h after instillation (mean score 24/48/72 h: 0.33 - 0.67). Ocular corrosion was not observed in any of the rabbits. No signs of systemic intoxication were observed during the study period. In conclusion, 1,1'-(1,1,2,2-tetramethylethylene)dibenzene was considered as not irritating to the eye.
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