Registration Dossier
Registration Dossier
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EC number: 915-277-1 | CAS number: 32052-51-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-09-25 to 1984-10-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate
- EC Number:
- 915-277-1
- Cas Number:
- 32052-51-0
- Molecular formula:
- C11H18N2O2
- IUPAC Name:
- 2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate
- Test material form:
- other: liquid
- Details on test material:
- 2,2,4-/2,4,4-trimethylhexane-1,6-diisocyanate of Hüls AG, purity > 99.0 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Small white Russian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Strain: Small white Russian, Chbb-SPF
- Sex: male/female - Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.3 - 2.5 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
Housing conditions:
- Room temperature: 20°C (+/- 1°C)
- Humidity: 60% (+/- 5%); light: 12 hours/day
- Air exchange: 15-fold/h
- Access to drinking water: ad libitum
- Diet: K4 diet for rabbits (Ssniff; Soest)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- not rinsed
- Observation period (in vivo):
- 1, 24, 48, 72 hours, 6, 8, 10, 13, 15, 17, and 21 days after treatment
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, 6, 8, 10, 13, 15, 17, and 21 days after treatment
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.22
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.61
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.61
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.39
- Max. score:
- 4
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 21 d
- Score:
- 23.62
- Max. score:
- 110
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 1.22
- Iris: 0.61
- Conjunctivae (Redness): 2.61
- Conjunctivae (Chemosis): 1.39
- Overall irritation score: 23.62/110
REVERSIBILITY: Not reversible within 3 weeks. Eyelids were incrusted in 5 animals on days 15 and 17 and in 1 animal on day 21. - Other effects:
- OTHER EFFECTS: Brightness reduced in eyes of 3 animals, redness in iris of all animals (24 until maximum 72 hours), sticking and dryness in the
eyes of the females (days 2-10), eyelids inelastic in all animals from day 3 on and incrusted later, loss of hair in all animals by end of study
Any other information on results incl. tables
no further results
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test item 2,2,4 -/2,4,4 -trimethylhexane-1,6 -diisocyanate showed severe damage on the eyes and mucosa
of male and female rabbits.y. The effects are not reversible within 3 weeks. - Executive summary:
The acute eye irritation properties of 2,2,4 -/2,4,4 -trimethylhexane-1,6 -diisocyanate were estimated in a Draize test according to OECD TG 405. An amount of 0.1 ml of the undiluted test substance was instilled into the left eye of three male and three female albino rabbits, and the untreated right eye served as control. The eye remained unrinsed and there was no removal of test substance. The undiluted substance produced reduced brightness in eyes of 3 animals, redness in iris of all animals (24 until maximum 72 hours), sticking and dryness in the eyes of the females (days 2 -10), eyelids inelastic in all animals from day 3 on and incrusted later, loss of hair in all animals by end of study. The effects are not reversible within 3 weeks.
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