2-Propanone, reaction products with diphenylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1 August 1983 - 4 August 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to GLP reguations of the FDA effective 20/06/1979.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.42.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Propanone, reaction products with diphenylamine

EC Number:

270-192-0

EC Name:

2-Propanone, reaction products with diphenylamine

Cas Number:

68412-48-6

Molecular formula:

Variable.

IUPAC Name:

N-cyclohexylcyclohexanamine; propan-2-one

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Source: UNIROYAL, INC
Received: 28/07/1983
Label: Aminox CN 5731
Storage: The test article was stored at ambient room temperature and humdity.
Description of Test Article: Yellow Powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Six healthy albino rabbits, free from evidence of ocular irritation, were selected for this test from a larger group which had been quarantined at least one week. The animals were received from Ace Animals 28/06/1983, 04/07/198 and 19/07/1983.
The animals were identified by cage notation and a uniquely numbered metal ear tag.
The animals were housed 2 per cage in suspended wire mesh cages. Bedding was placed beneath the cages. Fresh Purina Rabbit Chow (Diet #53-21) and water were freely available.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled and was kept clean and vermin free.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Equivalent to 0.1 mL

Duration of treatment / exposure:

Exposure time: 72 hours

Observation period (in vivo):

Observations: 24, 48 and 72 hours after dosing.

Number of animals or in vitro replicates:

Six

Details on study design:

Experimental design
The test article was placed by syringe or syringe-type applicator into the conjunctival sac which was performed by getly pulling the loewer eye lid away from the eye. After instillation, the lids were held together briefly to ensure adequate distribution of the test article. One eye of each rabbit was dosed. The contralateral eye served as a control.

Type and frequency of observations
The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva on Days 1, 2 and 3. Occular reactions were graded according to the numerical Draize technique. Additional signs were described. The general health of the aminals was monitored at each observation time.

Analysis of data
The primary eye irritation score for each rabbit was calculated from the weighted Draize scale.
The irritation potential was determined by counting the number of rabbits with positive irritation. Positive irritation is defined as any score for opacity or iritis or 2 or more for redness or chemosis. The test article is an irritant if 4 or more rabbits had a positive score at any time period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 11

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 15

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #4

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 16

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 18

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 20

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 22

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 23

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 24

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

There was no corneal opacity, iritis or moderate conjunctival irritation. Four of six eyes had slight conjunctival irritation which cleared by day 3.

Other effects:

None

Any other information on results incl. tables

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9544-F	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	1	0	0
	E		Chemosis	0	0	0
	F		Discharge	0	0	0
		3. Conjunctiva Total = (D+E+F) x 2		2	0	0
	Totals added = 1+2+3			2	0	0

 

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9560-M	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	0	0	0
	E		Chemosis	0	0	0
	F		Discharge	0	0	0
		3. Conjunctiva Total = (D+E+F) x 2		0	0	0
	Totals added = 1+2+3			0	0	0

 

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9565-M	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	1	1	0
	E		Chemosis	0	0	0
	F		Discharge	1	0	0
		3. Conjunctiva Total = (D+E+F) x 2		4	2	0
	Totals added = 1+2+3			4	2	0

 

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9585-F	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	1	1	0
	E		Chemosis	0	0	0
	F		Discharge	1	1	0
		3. Conjunctiva Total = (D+E+F) x 2		4	4	0
	Totals added = 1+2+3			4	4	0

 

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9667-M	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	0	0	0
	E		Chemosis	0	0	0
	F		Discharge	1	0	0
		3. Conjunctiva Total = (D+E+F) x 2		2	0	0
	Totals added = 1+2+3			2	0	0

 

Rabbit No.	Item	Tissue	Reading	Day 1	Day 2	Day 3
A9670-M	A	Cornea	Opacity Area	0	0	0
	B	1. Corneal Total = (AxB)x5		0	0	0
	C	Iris 2. Iris Total = Cx5		0	0	0
	D	Conjunctiva	Redness	1	1	0
	E		Chemosis	0	0	0
	F		Discharge	1	0	0
		3. Conjunctiva Total = (D+E+F) x 2		4	2	0
	Totals added = 1+2+3			4	2	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: 16 CFR 1500.42.

Conclusions:

There was no corneal opacity, iritis or moderate conjunctival irritation. Four of six eyes had slight conjunctival irritation which cleared by Day 3. In conclusion the test article is a non-irritant

Executive summary:

The objective of the study was to identify the irritation potential of the test material Aminox CN 5731 when instilled into the rabbit eye. The study was conducted in accordance to GLP and FHSA 16 CFR 1500.42. Results revealed there was no corneal opacity, iritis or moderate conjunctival irritation. Four of six eyes had slight conjunctival irritation which cleared by Day 3. In conclusion the test article is not irritating to rabbit eyes.