Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 10, 2015 - March 31, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)

EC Number:

310-133-9

EC Name:

Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)

Cas Number:

69997-91-7

Molecular formula:

C36H32CrN8O8S2.1/2C6H16N2.H

IUPAC Name:

Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)

Details on test material:

- Physical state: Solid / red
- Storage condition of test material: Room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 6 - 8 months
- Weight at study initiation: 3.50 kg – 4.34 kg
- Housing: Single housing in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm2
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): Approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March 16, 2015 To: March 30, 2015

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: Minimally moistened with highly deionized water

Controls:

other: Untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Flank
- Type of wrap if used: The test item was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol® and Lutrol® / water (1 : 1).

SCORING SYSTEM: according to OECD guideline 404:

Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well- defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to eschar formation preventing grading of erythema

Edema formation
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well- defined by definite raising)
3: Moderate edema (raised approx. 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

all three animals

Time point:

24/48/72 h

Score:

0.8

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

In two animals very slight erythema (grade 1) was noted immediately after removal of the patch and persisted in one of these animals up to hour 24. In the other animal well-defined erythema (grade 2) was observed from hour 1 until hour 24 after removal of the patch. Thereafter, erythema decreased to very slight erythema (grade 1) from hour 48 until hour 72. Due to the red discoloration of the application area, erythema was not assessable immediately and one hour after removal of the patch in the third animal. Thereafter, erythema could be determined and very slight erythema (grade 1) was observed from hour 24 until hour 48. The cutaneous reactions were reversible in two animals within 72 hours and in one animal within 7 days after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the described cutaneous reactions as well as the average score for irritation, the test article does not show a skin irritating potential under the test conditions chosen.

Executive summary:

The potential of the test article to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and on study day 7. Very slight to well-defined erythema (grade 1 to 2) were recorded during the course of the study. Due to the red discoloration of the application area, erythema was not assessable in one animal immediately and one hour after removal of the patch. The cutaneous reactions were reversible in two animals within 72 hours and in one animal within 7 days after removal of the patch. Mean scores over 24, 48 and 72 hours for each animal were 0.7, 1.3 and 0.3 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test article does not show a skin irritating potential under the test conditions chosen.