1,3-isobenzofurandione, reaction products with methylquinoline and quinoline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data is from Study report

Data source

Reference

Reference Type:

other: study report

Title:

DERMAL, EYE, AND ORAL TOXICOLOGICAL EVALUATIONS Phase Report-II

Author:

Indu A. Muni, Elliot B. Gordon, Jane B. Goodband

Year:

1986

Bibliographic source:

Bioassay Systems Corporation 225 Wildwood Avenue Woburn, MA 01801

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Data from study report

Principles of method if other than guideline:

Skin irritation study was conducted for the test chemical CI Solvent yellow 33

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,3-isobenzofurandione, reaction products with methylquinoline and quinoline

EC Number:

232-318-2

EC Name:

1,3-isobenzofurandione, reaction products with methylquinoline and quinoline

Cas Number:

8003-22-3

Molecular formula:

C18H11NO2

IUPAC Name:

2-(quinolin-2-yl)-2,3-dihydro-1H-indene-1,3-dione

Details on test material:

- Name of test material (as cited in study report): D&C Yellow No. 11
- Molecular formula (if other than submission substance): C18H11NO2
- Molecular weight (if other than submission substance): 273.29
- Substance type: Organic
- Physical state: Solid
- SMILES:O=C1C(c2ccc3ccccc3n2)C(=O)c2ccccc12

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Pine Acres Rabbi try, West Brattleboro, Vermont
- Age at study initiation: 8-15 weeks
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Individualy in stainless steel cages
- Diet (e.g. ad libitum): Fed Charles River Rabbit Formula (Agway) ad libitum
- Water (e.g. ad libitum): untreated municipal water via water bottle
- Acclimation period: 2 weeks

Or Test Tissue
- Source: No data available
- Type: No data available
- Acclimation : No data available
- Housing conditions: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was controlled to provide a 12 hr light cycle (7AM to 7PM)

IN-LIFE DATES: From: To: No data available

Test system

Type of coverage:

other: Closed

Preparation of test site:

other: Abraded and unabraded skin

Vehicle:

physiological saline

Controls:

not specified

Amount / concentration applied:

0.5g

Duration of treatment / exposure:

24 Hrs

Observation period:

24, 48 and 72 hrs

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Trunk
- % coverage: No data available
- Type of wrap if used: Gauze pad moistened with saline was secured with surgical tape to the abraded and unabraded skin sites of animals. The trunk of the rabbit was wrapped in plastic wrap and then stockinette to prevent removal of the patches by the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed but excess test material was removed by wiping.
- Time after start of exposure:

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: Erythema and eschar/edema

Time point:

other: 24hrs and 72 hrs

Score:

0.02

Max. score:

8

Reversibility:

no data

Remarks on result:

other: Irritation parameter: Negative

Irritant / corrosive response data:

Irritation parameter: Negative

Other effects:

Using the dual erythema and eschar/edema scales of Draize, add the average value of erythema and eschar responses at 24 and 72 hours for intact skin to the average values on abraded skin at 24 and 72 hours (total of 4 values before addition). Similarly, add the vaiues for edema formation at 24 and 72 hours for intact and abraded skin (4 values). The "value" recorded for each reading is the average value of the six or more animals subject to the test.
The sum of the eight values is divided by 4 to give the Primary Irritation Score. Compounds producing primary irritation scores of 0 are Non irritating. Irritation scores greater than 0 and less than or equal to 0.5 are practically non-irritating. Primary Irritation scores of 0.6 to 2 are only mildly irritating; whereas those with indexes from 2.1 to 5.4 are moderate irritants. and those with scores above 5.5 are considered severe irritants.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The primary irritation score for the test material CI Solvent Yellow 33 is found to be 0.02. Hence the compound is non –irritating to the skin of rabbits.

Executive summary:

Primary dermal irritation study was conducted on 6 male/female rabbits to evaluate the irritation potency of the test chemical materialCI Solvent Yellow 33. 0.5g of solvent yellow 33 was applied to the abraded and unabraded sites of test rabbits.

The test sites were exposed for 24 hours at which time the rabbits were unwrapped and the test sites scored for irritancy using the method of Draize. The test sites were again scored at 72 hours. In studies where irritation persisted at 72 hours, additional scoring was made for all test sites at day 7. Similarly, irritation on day 7 would trigger further examination at day 14. The last day of scoring, if irritation was present on day 14, was day 21.

Application of 0.5 g of to 2 abraded and 2 unabraded test sites of 6 rabbits for 24 hours produced barely perceptible erythema to one abraded test site of one rabbit. This erythema resolved by 72 hours. There was no edema observed at any of the test sites at the 24 and 72 hour observation periods. The Primary Irritation Score for this test sample was 0.02 (practically non-irritating). Clinical signs indicative of systemic toxicity were not observed.

Hence the compound is non –irritating to the skin of rabbits.

In accordance with the CLP classification, the test material does not classify as a skin irritant.