Mixture of reaction products of substituted copper phthalocyanine, hydrogenated resin acids, alkaline earth metal chlorides, and copper phthalocyanine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 June 2008 - 27 June 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(2004)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

B508

IUPAC Name:

B508

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: B508
- Physical state: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan, Gannat, France
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: 1500 - 1832 g
- Housing: Individually in labelled cages with perforated floors
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 7 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9 -21.2
- Humidity (%): 42 - 67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: aqueous ethanol (50% v/v)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- pH of a 1% aqueous solution: 7.0-7.8
- Amount(s) applied (volume or weight with unit): 0.5 grams of the test substance moistened with 0.5 mL of watery ethanol (50% v/v) as the substance did not mix with water

Duration of treatment / exposure:

4 hours

Observation period:

up to 72 hours

Number of animals:

3 males

Details on study design:

STUDY DESIGN
The study was performed in a stepwise manner and was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner one week later, after considering the degree of skin irritation observed in the first animal.

TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.

The test substance was moistened with 0.5 mL of watery ethanol (50% v/v) and applied to the skin of one flank, using a metalline patch# of 2x3 cm.

REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water and watery ethanol (50% v/v) (water: Elix, Millipore S.A.S., Molsheim, France; ethanol: Merck, Darmstadt, Germany).

OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application) and at termination
- Necropsy: No histopathology was performed, since the skin reactions were not masked by test substance staining.
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
The irritation was assessed using the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

4

Remarks on result:

other: Blue staining of the skin by the test substance.

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2 and #3

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin irritation was caused by 4 hours exposure to the test substance.

Other effects:

Blue staining of the treated skin by the test substance was observed throughout the observation period which did not hamper the scoring of the skin reactions. No test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. The body weight loss of animal number 880 observed at the end of the study was considered not indicative of toxicity, based on the absence of any corroborative findings in this animal.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a skin irritation study with rabbits, performed according to OECD 404 test guideline and GLP principles, no irritation was observed.

Executive summary:

Three male rabbits were exposed to B508 for 4 hours using a semi-occlusive dressing, according to OECD 404 test guideline and GLP principles.

No skin irritation was caused by 4-hour exposure to the test substance. Blue staining of the treated skin by the test substance was observed throughout the observation period which did not hamper the scoring of the skin reactions. No test substance remnants were seen. No symptoms of systemic toxicity were observed in the animals and no mortality occurred. B508 is not irritating to skin and no classification is needed according to EC regulation 1272/2008.