N-(cyclohexylthio)phthalimide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(cyclohexylthio)phthalimide

EC Number:

241-774-1

EC Name:

N-(cyclohexylthio)phthalimide

Cas Number:

17796-82-6

Molecular formula:

C14H15NO2S

IUPAC Name:

N-(cyclohexylthio)phthalimide

Details on test material:

Test batch No.: 041/07
Active substance: 99,42 % weight
Weight loss: 0,08 % weight
Toluene insolubles: 0,05 % weight
Ash: 0,008 % weight
Melting point: first liquid 92,3°C
complete liquid 92,5 °C
Sieve retention: 2,0 mm 0 %
0,5 mm 0 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Number and Sex: Four healthy young adult animals (males), weighing from 3,20 kg to 3,89 kg
Source: VÚŽV Nitra, Slovakia

Identification: The animals were housed individually in cages. The animals were marked by serial numbers 1 - 4. These numbers were placed on the cage and on the auricle.

Housing: Animals were housed in cages individually.

Diet: A standard certified laboratory diet ( supplier Top DOVO Dobrá Voda) was served.

Water: Ad libitum

Environment: Environmental controls for the animal room was set to maintain 18± 3°C, a relative humidity of 40 - 70 %a minimum of 10 air changes/hour, and a natural light regime.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Olivae oleum raffinatum

Controls:

other: each animal served as its own control

Amount / concentration applied:

The test article was applied in a single dose to the clipped skin of experimental animals, each animal serving as its own control. A dose of 0,5 g Duslin was pulverised , moistened with olivae oleum and applied to the intact skin of rabbits for 4 h under semi-occlusive dressings.

The study was begun with an initial test using one animal. The test article was applied to a small ares (approximately 6 cm2 ) of skin and covered with a gauze patch. The patch was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period (4h). At the end of the exposure period, residual test preparation was removed using with olivae oleum. Because a corrosive effect was not observed in initial test, the irritant response was confirmed using up to three additional animals simultaneously.

Duration of treatment / exposure:

Duration: 4h

Observation period:

Observation period: 1h, 24h, 48h and 72h after test

Number of animals:

four animals: albino rabbits (males)

Details on study design:

The study Duslin. Acute toxicity:Dermal Irritation/Corrosion (OECD 404) was performed according to SOP 001/215/03 in complince with the OECD
Guidelines for Testing of Chemicals - Method No 404 Acute Dermal Irritation/Corrosion, 2002 (OECD 404) and Principle of Good Laboratory Practice.

Evaluation of results:
For acute exposure, the Primary Irritation Index (PII) was determined as follows:
1. For each animal, the Irritation Scores for both erythema and oedema at each time specified were added together and divided by the total number of observations. Only 24h, 48h, 72h obsevations were used for calculations.
2. The irritation scores of each animal were added and divided by total number of animals. This value is the Primary Irritation Index.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

1,1

Basis:

animal #1

Time point:

other: after 24, 48 and 72 h

Score:

>= 1 - <= 2

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

1,1

Basis:

animal #2

Time point:

other: after 24, 48, 72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

1,1

Basis:

animal #3

Time point:

other: after 24, 48, 72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: weeping skin was appeared

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

1,1

Basis:

animal #4

Time point:

other: after 24, 48, 72 h

Score:

>= 2 - <= 3

Max. score:

4

Reversibility:

fully reversible

Irritant / corrosive response data:

The degree of irritation was read and scored at specified intervals (1h, 24h, 48h and 72h following removal of the patches) and was described to
provide a complete evaluation of the effects.

Other effects:

The Primary Irritation Index of Duslin for single exposure determined in this study was PII = 1,1. According to this value the test article belongs to
response category "Slight".

Any other information on results incl. tables

The moderate erythema classified as grad 3 was observed as the worst skin reaction on the Duslin. We did not observe erythema and oedema on the vehicle application site. During 7 days after removal of patches erythema was disappeared by all animals, but in animal No. 3 weeping skin was appeared. No oedema was occurred in the course of study.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS