[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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-100-9

EC Name:

-

IUPAC Name:

404-100-9

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf/Switzerland
- Age at study initiation: males: 12 weeks; females: 12 weeks
- Weight at study initiation: males: 297 - 337 g; females: 224 - 260 g
- Housing: Individually 1n Makrolon type-2 cages with standard softwood bedding ("Lignocel", Schill AG, 4132 Muttenz/Switzerland).
- Diet: Pelleted standard Kliba 343, Batch 31/88 and 34/88 rat maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Kaiseraugst/Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: At least one week under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 40-70 %
- Air changes: 10-15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent Iight/12 hours dark, music/light period.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

Approximately 24 hours before treatment, the backs of the animals were shaved with an electric clipper, exposing an area of approximately 10 % of the total body surface. On test day 1 the test article was applied evenly on the skin with a syringe and covered with an occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage. Twenty-four hours after the application, the dressing was removed. The treated skin was washed with lukewarm tap water, dried with disposable paper towels and the skin reaction was assessed according to the method of Noakes and Sanderson (Br J Ind Med; 1969; 26:59-64).

Application volume/kg body weight: 4 ml at 2000 mg/kg

Rationale:
The dermal administration was used because this is one possible route of human exposure during manufacture, handling and use of the test article.

Duration of exposure:

24 hours

Doses:

Application volume/kg body weight: 4 ml at 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: Four times during test day 1, and daily during days 2 - 15.
- Frequency of weighing: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

LOGIT model could not be applied.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen throughout the observation period.

Clinical signs:

other: The following local findings were observed: erythema (females), blue discolored application area. The female rats had recovered from erythema within 12 observation days, whereas blue discolored application area was observed until termination of test in an

Gross pathology:

No macroscopic organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD50 of FAT 40336/B was estimated to be >2000 mg/kg bw.

Executive summary:

FAT 40336/B was assessed for toxicological potential when administered to rats by a single occlusive dermal application, with an observation period of 15 days. The test article FAT 40336/B was applied to the shaved skin of rats of both sexes for 24 hours at a dose of 2000 mg/kg bw. No mortality was observed. Therefore, the dermal LD50 of FAT 40336/B was estimated to be >2000 mg/kg bw.