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Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Correlation of Ocular and Dermal Irritancy of Industrial Chemicals
Author:
Shayne C. Gad, Robert D. Walsh & Brendan J. Dunn
Year:
1986
Bibliographic source:
Journal of Toxicology: Cutaneous and Ocular Toxicology; Vol 5(3); Pg. no. 195-214; 1986.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize method
Principles of method if other than guideline:
Skin irritation study was performed on New Zealand White rabbits to evaluate the irritation potential of potassium phthalimide
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-potassium phthalimide
EC Number:
214-046-6
EC Name:
N-potassium phthalimide
Cas Number:
1074-82-4
Molecular formula:
C8H5NO2.K
IUPAC Name:
potassium 1,3-dioxo-1,3-dihydroisoindol-2-ide
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): Phthalimide, potassium salt
- Molecular formula :C8H5NO2.K
- Molecular weight 185.223 g/mol
- Smiles notation : c12c(C(=O)[NH-]C1=O)cccc2.[K+]
- InChl: 1S/C8H5NO2.K/c10-7-5-3-1-2-4-6(5)8(11)9-7;/h1-4H,(H,9,10,11);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Phthalimide, potassium salt
- Molecular formula : C8H5NO2.K
- Molecular weight 185.223 g/mol
- Smiles notation : c12c(C(=O)[NH-]C1=O)cccc2.[K+]
- InChl: 1S/C8H5NO2.K/c10-7-5-3-1-2-4-6(5)8(11)9-7;/h1-4H,(H,9,10,11);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Details on test animal
TEST ANIMALS
Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Accilmation Period:Animals were held for 14 days after arrival in the facility but prior to use in tests to ensure that they are healthy.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and non abraded
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
0.5g
Duration of treatment / exposure:
24 hours
Observation period:
Observations were made at 25, 48 and 72 hrs.
Number of animals:
6
Details on study design:
Controls: Each animal served as its own control.As well as the test substance, a positive control substance (a known skin irritant, 1 % sodium lauryl sulfate in water) and a negative
control (plain gauze patch) are applied to the skin. Vehicle control was also used in case vehicle was used for the test substance.

TEST SITE
- Area of exposure: Rabbit’s back side was exposed with the test substance.
- % coverage: No data available
- Type of wrap if used: Saran Wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing of the test substance with an appropriate solvent or vehicle is done if the test substance applied is a colored test substance (such as dye).
- Time after start of exposure: No data available

SCORING SYSTEM: Dermal irritation scores for erythema and edema formation was evaluated by the scale proposed by Draize.

Persistent irritation score are also recorded, as well as the occurrence of eschar (+ E) and/or necrosis (+ N).

Results and discussion

In vitro

Other effects / acceptance of results:
No data available

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
2.3
Max. score:
8
Reversibility:
not specified
Remarks on result:
probability of moderate irritation
Irritant / corrosive response data:
Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs.

Any other information on results incl. tables

Table 2: Dermal Irritation Results and Classification

Chemical type

Classification

PDII

FHSA

Potassium phthalimide

Moderate

2.3

Irritant

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs. The Primary Dermal Irritation Index (PDII) for Potassium Phthalimide after 24 hours was 2.3
Based on the scores, Potassium phthalimide can be considered to be moderate skin irritant.
Executive summary:

Skin irritation study was performed on New Zealand White rabbits to evaluate the irritation potential of potassium phthalimide. 6 New Zealand White rabbits were used for the study.Animals were held for 14 days after arrival in the facility but prior to use in tests to ensure that they are healthy. Each animal served as its own control. Along with the test substance, a positive control substance (a known skin irritant, 1% sodium lauryl sulfate in water) and a negative control (plain gauze patch) are applied to the skin. A vehicle control patch was also used in case the chemical was moistened with a vehicle or suspended in vehicle. Four test sites, two on each side of the rabbit's back, were utilized for administration of test chemical and controls.

A standard random pattern of administration ensured that the test substance and controls are applied to each position at least once in each test group. Each test or control substance is held in place with a 1x1 inch2 12-ply surgical gauze patch. The gauze patch is applied to the appropriate skin site and secured with 1-inch wide strips of Blenderm surgical tape, at the four edges, leaving the center of the gauze patch non-occluded. A 0.5-g portion of Potassium Phthalimide was weighed and placed on the gauze patch prior to application of the patch. The test substance and patch are then placed on the appropriate skin site and secured. The patch is subsequently moistened with 0.5 ml physiological saline.The study was on performed on both abraded and non-abraded animals.The negative control site is covered with an untreated 12-ply surgical gauze patch (1X1 inch2). The impervious material (Saran Wrap) aids in maintaining the position of the patches and retards evaporation of volatile test substances.

A Saf-T-Shield collar is fitted and fastened around the neck of each test animal. The collar remains in place for a 24 hr exposure period. The collar prevents the animal from removing the wrapping and patches.After the exposure period, the test substance skin site is wiped with dry gauze to remove any test substance still remaining.Dermal irritation scores for erythema and edema formation was evaluated by the scale proposed by Draize.The primary dermal irritation index (PDII) was calculated by dividing the sum of total irritation scores by the number of observations, and classifying the test substance:

0.00 = non-irritant ,>0.00 - 0.50 = negligible irritant, >0.50 -2.00 = mild irritant, >2.00-5.00 = moderate irritant, >5.00-8.00 = severe (primary) irritant.

 

 

Moderate irritation effect was observed when the rabbits were exposed to the test substance potassium phthalimide for 24 hrs. The Primary Dermal Irritation Index (PDII) for Potassium Phthalimide after 24 hours was 2.3

Based on the scores, Potassium phthalimide can be considered to be moderate skin irritant.

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