Reaction mass of diisobutyl adipate and diisobutyl glutarate and diisobutyl succinate

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:

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

Test material information

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

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%

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Results 7

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

Results 8

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

Results 9

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

Results 10

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

Results 11

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

Results 12

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

Results 13

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

Results 14

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

Results 15

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

Results 16

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

Results 17

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

Results 18

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.