6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9/28/92 - 9/30/92

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This test should be used viewed on a weight of evidence approach as not OECD method. But it was completed per GLP and according to 49 Code of Federal Regulations 173:132 (USA) (US Department of Transport Protocol).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 49 Code of Federal Regulations 173:132 (USA) (US Department of Transport Protocol).

Principles of method if other than guideline:

A single dose of 2000 mg of CP-89,575/kg was applied to an approximately 240 cm2 (15 x 16 cm) area of intact skin that was premoistened with normal saline. The test material was held in continuous contact with the skin under an occlusive dressing for 24 hours. The rabbits were observed for clinical signs of toxicity and gross skin changes at
least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all
pertinent study information. The animals were dosed on 9/28/92 {day 1) and euthanized by intravenous sodium pentobarbital overdose on 9/'30/92 {day 3).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

EC Number:

421-320-0

EC Name:

6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one

Cas Number:

118289-55-7

Molecular formula:

Hill formula: C10 H9 Cl2 N O CAS formula: C10 H9 Cl2 N O

IUPAC Name:

6-chloro-5-(2-chloroethyl)-2,3-dihydro-1H-indol-2-one

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

DESCRIPTION: A fine, orangish-brown powder with white flecks
MOLECULAR FORMULA: C10H9Cl2NO MOLECULAR WEIGHT: 230.09

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

SOURCE: Millbrook Farm
SEX: 3 Males, 2 Females
WEIGHT RANGE: 3.13 to 3.44 kg
The rabbits were observed for clinical signs of toxicity and gross skin changes at
least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all
pertinent study information.

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: The test area was pre-moistened with normal saline.

Controls:

no

Amount / concentration applied:

2000 mg

Duration of treatment / exposure:

24 h

Observation period:

2 days

Number of animals:

5

Details on study design:

A single dose of 2000 mg of CP-89,575/kg was applied to an approximately 240 cm2 (15 x 16 cm) area of intact skin that was premoistened with normal saline. The test material was held in continuous contact with the skin under an occlusive dressing for 24 hours. The rabbits were observed for clinical signs of toxicity and gross skin changes at least once daily for 2 days after dosing and were weighed daily. Each animal was identified with a unique ear tattoo number and each cage was labeled with a card containing all pertinent study information.

The animals were dosed on 9/28/92 {day 1) and euthanized by intravenous sodium pentobarbital overdose on 9/'30/92 {day 3). Doses were calculated on a weight basis (i.e., mg of compound as supplied/kg); the purity (activity) of the compound (95.6%) was not taken into consideration for dose calculations. The stability of the test article under the conditions of the study was not determined.
A standardized scoring system was used to evaluate skin changes at the application site. Draize scoring. (Draize, J. H., Woodard, G., and Calvery, H. 0.: Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes.J. Pharmacol. Exptl. Therap., 82:3n - 390, 1944)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

SKIN CHANGES: No erythema, edema, or other signs of skin irritation were noted in any of the rabbits during the observation period (72 hours)

Other effects:

CLINICAL OBSERVATIONS: All rabbits remained asymptomatic during the test period, and there was no effect on food consumption or body weight.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Results of this test indicate that because no signs of skin irritation were produced, CP-89,575 is not considered a an irritant.