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EC number: 907-870-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Test material dosed into right eye of 2 rabbits. 20 seconds after treatment one treated eye was washed. Observations of cornea, iris and conjunctiva made at 1 and 4 hours and 1, 2, 3, 7 and 15 days post treatment.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
- IUPAC Name:
- Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
- Reference substance name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- EC Number:
- 907-870-9
- Molecular formula:
- Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
- IUPAC Name:
- 1,4-bis(2-methylpropyl) butanedioate; 1,5-bis(2-methylpropyl) pentanedioate; 1,6-bis(2-methylpropyl) hexanedioate
- Details on test material:
- 34% diisobutyl succinate
55% diisobutyl glutarate
11% diisobutyl adipate
Overall purity >99.9%
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- 1 rabbit - 20 seconds
1 rabbit - 1 minute - Observation period (in vivo):
- 1h, 4h, 1, 2, 3, 7 and 15 days
- Number of animals or in vitro replicates:
- 2 (males)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- uwashed eye
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- unwashed eye
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- washed eye
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- washed eye
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- washed eye
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- washed eye
- Time point:
- other: 4 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- unwashed eye
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- unwashed eye
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: one day
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Unwashed eye:
Cornea: some slight clouding at 1h, 4h and 3 -7 days. Small area of slight clouding at days 1 and 2. No effects apparent at 15 days
Iris: Slight swelling at days 2 -3 only
Conjunctiva: mild redness at day 1 only; slight swelling at 4 hrs and day 1; mild discharge at 4 hr and 3 days
All effects resolved by day 7 or 15.
Washed eye:
Cornea: local area of slight clouding at 1hr and 1 day only
Iris: No effects
Conjunctiva: No redness, Slight swelling at 1 and 4 hours; mild discharge at 4 hours only
Overall there were minimal signs of irritation in each animal. These effects do not appear to be significant or sufficiently severe to warrant classification for eye irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Although signs of mild irritation were observed they appear to be slight/mild and do not appear to meet the criteria for classification as irritating to the eyes.
- Executive summary:
1/10 ml of undiluted material dosed to the conjunctival sac of the right eye of each of two rabbits. At 20s after dosing the treated eye of one rabbit was washed with tap water for 1 minute. The treated eye of the second rabbit remained unwashed. Observations of the cornea, iris and conjunctiva were made as indicated above. Draize scoring was not used, instead the effects were marked qualititatively. Although signs of mild irritation were observed they appear to be slight/mild and do not appear to meet the criteria for classification as irritating to the eyes.
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