TOMILAC 214

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 to 15 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Recently conducted GLP compliant study using the most recent test methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): JKY-214
- Physical state: white solid
- Analytical purity: No information
- Lot/batch No.: Y002E
- Expiration date of the lot/batch: No information
- Stability under test conditions: No information. Assumed stable due to no data to the contrary
- Storage condition of test material: room temperature in the dark
- Other:

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan France SARL
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): Free access to food (Certified Rabbit Diet)
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least five days each animal


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness


IN-LIFE DATES: not reported

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test material
- Concentration (if solution): n/a


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml of distilled water to moisten
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a

Duration of treatment / exposure:

One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area under a 2.5 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done.
- Time after start of exposure: n/a


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 and 72 hrs

Score:

0

Max. score:

0

Reversibility:

other: no observations

Irritant / corrosive response data:

no irritation observed

Other effects:

none

Any other information on results incl. tables

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.46-59:

Primary Irritation Index                  Classification of Irritancy

0                                              Non-irritant

> 0 to 2                                        Mild irritan

>    2 to 5                                     Moderate irritant

>   5 to 8                                       Severe irritant

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.

Individual Skin Reactions Following 3-Minute and 1-Hour Exposures

Skin Reaction	Observation Time	Individual Scores - Rabbit Number and Sex
		67154 Male
		3-Minute Exposure	1 -Hour Exposure
Erythema/Eschar Formation	1 Hour	0	0
	24 Hours	0	0
	48 Hours	0	0
	72 Hours	0	0
Oedema Formation	1 Hour	0	0
	24 Hours	0	0
	48 Hours	0	0
	72 Hours	0	0

Individual Skin Reactions Following 4-Hour Exposure

Skin Reaction	Observation Time	Individual Scores - Rabbit Number and Sex			Total
		67154 Male	67189 Male	67190 Male
Eiythema/Eschar Formation	1 Hour 24 Hours  48 Hours 72 Hours	0 0  0 0	0 0 0 0	0 0 0 0	0 0 0 0
Oedema Formation	1 Hour	0	0	0	(0)
	24 Hours	0	0	0	0
	48 Hours	0	0	0	(0)
	72 Hours	0	0	0	0

Sum of 24 and 72-hour Readings (S)             :              0

Primary Irritation Index (S/6)                           :              0/6 = 0.0

( ) = Total values not used for calculation of primary irritation index

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT. No corrosive effects were noted.

Executive summary:

The acute dermal irritation has been assessed by means of exposure to rabbits according to EU method B4 in compliance with GLP. As no corrosivity or irritation were observed during the study, the substance is considered not irritating.