[29H,31H-phthalocyaninato(2-)-kappa4N29,N30,N31,N32]copper, sulfonated, condensed with 2,4- diaminobenzenesulfonic acid and ammonia, converted with sodium hydroxide 2,4,6-trichloro-1,3,5-triazine and ammonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 24 February, 1987 to 27 February, 1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted May 12, 1981, by the OECD council)

Deviations:

yes

Remarks:

Occlusive testing conditions represent elevated testing conditions compared to today's standard protocols. Therefore, results need to be interpret with care.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride

EC Number:

942-002-2

Molecular formula:

C42.53H20.97Cl1.17N15.41Na3.62O13.95S5.17

IUPAC Name:

Reaction products of [29H,31H-phthalocyaninato(2-)-k4N29,N30,N31,N32]copper, thionyl dichloride, and sulfurochloridic acid, further condensed with 2,4-diaminobenzenesulfonic acid and ammonia, further converted with sodium hydroxide 2,4,6-trichloro-1,3, -triazine, and ammonium chloride

Test material form:

solid: particulate/powder

Remarks:

powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: Approx. 12 to 14 weeks
- Weight at study initiation: 2480 to 2780 g
- Housing: individually in metal cages
- Diet: Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland, ad libitum
- Water: Fresh water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 30-70 %
- Photoperiod: 12 h dark/12 h light

IN-LIFE DATES: From February 24, 1987 to February 27, 1987

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated contralateral flank of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE & APPLICATION
- An area of at least 6 cm² was shaved on both flanks of the animals approximately 24 h before treatment. A gauze patch (20 cm²) bearing 500 mg of the test substance was applied to the flank. A control gauze patch was applied to the contralateral flank. Both gauze patches were moistened before application with distilled water. The patches were loosely covered with an aluminum foil (36 cm² ) and held in place for 4 h by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

OBSERVATION: The animals were checked daily for systemic symptoms and mortality. The body weight was recorded at start and on Day 3 of the test.

SCORING SYSTEM: The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages.

Other effects:

There were no signs of body weight variability, toxicity or mortality in any animal during the study period.

Any other information on results incl. tables

Erythema:

Animal No. 72/F	136/M CF/TF	137/M CF/TF	138/M CF/TF
After 1 hr.	0/1	0/1	0/1
After 24 hrs.	0/0	0/0	0/0
After 48 hrs.	0/0	0/0	0/0
After 72 hrs.	0/0	0/0	0/0
Mean (24 – 72 hrs.)	0/0	0/0	0/0

 

Oedema:

 

Animal No. 72/F	136/M CF/TF	137/M CF/TF	138/M CF/TF
After 1 hr.	0/0	0/0	0/0
After 24 hrs.	0/0	0/0	0/0
After 48 hrs.	0/0	0/0	0/0
After 72 hrs.	0/0	0/0	0/0
Mean (24 – 72 hrs.)	0/0	0/0	0/0

 

CF = control flank TF = test flank M = male F = female

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was considered to be not irritating to the skin.

Executive summary:

A study was performed to assess the skin irritation potential of FAT 40045/C (of 100 % purity) in New Zealand White rabbits according to OECD Guideline 404. 500 mg of test substance was applied to a shaved skin area of 6 cm² on one flank of each animal under a 20 cm² gauze pad. The pad was allowed to remain in contact with the skin for 4 h. Animals were scored for irritation reactions after 1, 24, 48 and 72 h. FAT 40045/C induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. No signs of body weight variability, toxicity or mortality were observed in any animal. Based on these findings, the test substance was considered to be not irritating to skin.