Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 21/07/2006 to 02/08/2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to GLP compliance and International Guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Guideline for testing of chemicals Acute Eye Irritation/Corrosion

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

ACQUAPOL C1

IUPAC Name:

ACQUAPOL C1

Test material form:

other: liquid

Details on test material:

Test article: ACQUAPOL C1
Form: Aqueous solution of quaternary ammonium tannate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Test system:
Adult white albino rabbits (Oryctolagus cuniculus) of the New Zealand breed, weighing 1850-2200 gramsof live weigh, were used. the animals were healty and had no detectable pathological changes in the skin.
Environmental condition:
The animals were acclimated to the laboratory conditions at least 5 days prior to the beginning of the experiment. They were kept with ventilation of 10 to 15 air changes per room per hour and a photoperiod of 12 hours in the light and 12 hours in the dark. The diet comprised commercial pelletized feed, with supplemetnation of filtered water, both provided ad libitum. 3 animals were used, 3 males, which were kept individually in galvanized wire cages.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: test system used as control

Amount / concentration applied:

The test article Acquapol C1, originally in liquid form, was used pure. The total amount of the solution applied to the skin in each animal was 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

Approximately 24 hours before the beginning of the test, the hair in the region immediately posterior to the back of the neck were removed using shears for animals, with great care not to hurt and/or irritate the skin. The solution were applied to the small sheared area (approximately 6 cm2) on the back of the animals, and then protected by a gauze/occlusive patch. The untreated adjacent areas served as negative control. At the end of the exposure period (4 hours), the solution residues were removed by rising with water with the aid of cotton. The animals were maintained for 72 hours under observation, being clinically observed. and the lesion grades were noted ast 60 minutes, 24 hours, 48 hours and 72 hours after the application of the product. The animals were examinated for the presence of herythema, edema and formation of eschars, as well as other local or systemic changes.

Analysis of the results:
Each animal was separately evaluated and their results were put into individual table. The degrees of skin lesions were recorded in accordance with the scale in Table 1

Calculation of the skin irritation index:
To estabilish the Skin Irritation Index, the values for erythema and formation of eschars for 24 and 72 hours (2 values) were added to the values for edema formation for 24 and 72 hours (2 values). The total of these 4 values were divide by 2 and classified according to the criterion in table 2.
the edema evaluation was measured through paquimeter, and the calculation of the value of the edema was made through the formula:
(Lat/2) - (Lac/2) = Edmm
Lat= reading of the area tests (entire and with groove)
Lac= reading of the control area (entire and with groove)
Edmm= Value of the edema in millimeters

The graduation of the intensity of the cutaneous reaction was based in the method of Draize, according to the table 1

The calculation of the value of primary cutaneous irritation is accomplished through the toally of the aritmetic average divided by four of the following observations:
- Edema in the entire skin 24:00 hours
-Edema in the skin with groove 24:00 hours
- Eritema in the entire skin 24:00 hours
-Eritema in the skin with groove 24:00 hours
- Edema in the entire skin 24:00 hours
-Edema in the skin with groove 72:00 hours
- Eritema in the entire skin 72:00 hours
-Eritema in the skin with groove 72:00 hours

Classification class are defined in table 2

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24h, 48h, 72h

Score:

ca. 0

Reversibility:

fully reversible

Irritant / corrosive response data:

Skin Irritation Index:
Animal 1: 0, 0
Animal 2: 0, 0
Animal 3: 0,0
Average:0, 0

Classification: Non-irritative Clas IV: No irritation

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The concerning substance is consider non-irritant when applied on the skin and according to Reg.Ec 1272/2008

Executive summary:

The Primary Skin Irritation Test on rabbits, based on OECD guideline 404, is intended for providing information on the corrosive or irritative effects of a substance on the skin of mammals. The concerning substance showed a skin irritation index 0.0 and is consider non-irritant when applied on the skin in rabbits according to Reg.EC 1272/2008.

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