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Toxicological information

Eye irritation

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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:
other: Study appears well conducted and reproted in sufficient detail to make a judgement.. Protocol used was not consistent with current protocol but adequate for assessment of the endpoint.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
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

Constituent 1
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
Constituent 2
Chemical structure
Reference substance name:
Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
EC Number:
907-870-9
Molecular formula:
Diisobutyl succinate: C12O4H22 Diisobutyl glutarate: C13O4H24 Diisobutyl adipate: C14O4H26
IUPAC Name:
Reaction mass of bis(2-methylpropyl) pentanedioate and bis(2-methylpropyl) butanedioate and bis(2-methylpropyl) hexanedioate
Details on test material:
34% diisobutyl succinate
55% diisobutyl glutarate
11% diisobutyl adipate
Overall purity >99.9%

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:
unwashed eye
Time point:
7 d
Score:
1
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
14 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24 h
Score:
2
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
24/48/72 h
Score:
1
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
unwashed eye
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed eye
Time point:
24 h
Score:
1
Max. score:
1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
washed eye
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
washed eye
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
washed eye
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
washed eye
Time point:
other: 4 hours
Score:
1
Max. score:
1
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
unwashed eye
Time point:
24 h
Score:
0
Max. score:
0

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
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.