Registration Dossier
Registration Dossier
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EC number: 283-810-9 | CAS number: 84713-17-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985-10-15 to 1985-10-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
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)-trimethylhexanedinitrile
- EC Number:
- 283-810-9
- EC Name:
- 2,2,4(or 2,4,4)-trimethylhexanedinitrile
- Cas Number:
- 84713-17-7
- Molecular formula:
- C9H14N2
- IUPAC Name:
- 2,2,4-trimethylhexanedinitrile; 2,4,4-trimethylhexanedinitrile
- Details on test material:
- 2,2,4(or 2,4,4)-Trimethylhexanedinitrile of Hüls AG, purity 96.5 %, main impurity 1-cyano-2-imino-3,5,5-trimethylcyclopentane = 2.42 %
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
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Sex: male/female
- Weight at study initiation: 2.2 - 2.6 kg
- Number of animals: 3 males, 3 females
- Controls: untreated eye
- Housing: single housing
- Diet: ad libitum, special diet for rabbits, SSniff K4
- Water: ad libitum, tap water
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20.0 +/- 1 °C
- Humidity: 60 +/- 5 %
- Air changes: 15 times per hour
- Photoperiod: 12 hours artificial light, 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hour(s)
- Observation period (in vivo):
- Postexposure observation period: 6 days
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- EXAMINATIONS
- rinsed after 72 hours
- Ophtalmoscopic examination: 1, 24, 48, 72 hours, and 6 days after treatment
- Tool used to assess score: sodium fluorescein / ophthalmic lamp / visual inspections
- Scoring system: Draize (1959); evaluation: VCI notes on safety data sheet and Appendix VI of 79/831/EEC
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h
- Score:
- 1.75
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 28, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.06
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- AVERAGE SCORE
- Cornea: 0.0
- Iris: 0.0
- Conjunctivae (Redness): 0.06
- Conjunctivae (Chemosis): 0.0
- Overall irritation score: 1.75/110 - Other effects:
- REVERSIBILITY: complete within 48 hours
OTHER EFFECTS: vocalization and defense reaction directly after treatment in 1 animal
Any other information on results incl. tables
no further remarks
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize (1959); Appendix VI of 79/831/EEC
- Conclusions:
- Classification: not irritating
- Executive summary:
A study was performed to examine eye irritating effects of 2,2,4(or 2,4,4)-trimethylhexanedinitrile according to OECD TG 405 (1981) in rabbits. 0.1 ml of undiluted test substance was applied in the conjunctival sac of one eye per animal of six rabbits (3male, 3 female) without rinsing. The irritation index was 1.75 of max. 110. The effects were completely reversible within 48 hours. Directly after treatment one animal showed vocalization and defense reaction. Under conditions of the study 2,2,4(or 2,4,4)-trimethylhexanedinitrile showed no irritating effects in rabbits.
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