2-Isobutyryl-3,N-diphenylacrylamide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-01-04 to 1990-03-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study was conducted according to GLP guidelines as described by the FDA (21 CFR P

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

no guideline followed

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): 132,408
- Substance type: powder
- Physical state: solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc, Boyertown, PA
- Age at study initiation: young
- Weight at study initiation: not specified
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days

ENVIRONMENTAL CONDITIONS
All housing and care conformed to the standard established in the "Guide for the care and use of laboratory animal" DEHW Publication No. (NIH) 85-23

Test system

Vehicle:

not specified

Controls:

not required

Amount / concentration applied:

0.1 g into one eye of each rabbit

Duration of treatment / exposure:

72 hours for 6 animals
The eye of three animals was irrigated thoroughly with destilled water thirty seconds after the test article instillation until all visible test article was removed.

Observation period (in vivo):

72 hours
time points were 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

6+3
treatment of only one eye

Details on study design:

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 1 hour

Score:

12.3

Max. score:

19

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: non-irrigated

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 1 hour

Score:

4

Max. score:

6

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: irrigated 30 seconds after instillation

Irritant / corrosive response data:

Non irrigated group:
The test article instillation caused iritis and conjunctival irritation with blistering. No ocular irritation was present in one animal at the 24 hour reading and the remaining five animals at the 48 hour reading. The untreated eye of each animal appeared normal throughout the observation period. The maximum eye irritation score was 12.3 which was calculated from individual scores recorded one hour after the test article instillation.

Irrigated group:
The test article instillation caused iritis and conjunctival irritation with blistering. No ocular irritation was present in one animal at the 24 hour reading and the remaining two animals at the 48 hour reading. The untreated eye of each animal appeared normal throughout the observation period. The maximum eye irritation score was 4.0 which was calculated from individual scores recorded one hour after the test article instillation.

Other effects:

-

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

Under the conditions of this study, PD 132,408 is considered minimally irritating to rabbit eyes without irrigation and with irrigation 30 seconds after administration. Irrigation after 30 seconds reduced the severity of ocular irritation.

Executive summary:

The primary irritation potential of PD 132408 after the instillation into the eyes of male New Zealand white rabbits was examined in this study. Under the conditions of this study, PD 132,408 is considered minimally irritating to rabbit eyes without irrigation and with irrigation 30 seconds after administration. Irrigation after 30 seconds reduced the severity of ocular irritation.