Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD 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 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

108300-90-9

Cas Number:

108300-90-9

IUPAC Name:

108300-90-9

Details on test material:

- Name of test material (as cited in study report): Pigmentblau 1755
- Test substance No.: 85/565
- Physical state: blue powder
- Analytical purity: 95 %
- Lot/batch No.: P. 1+2 / 1985

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: males: ca. 247 g; females: ca. 202 g
- Housing: 5 animals per cage in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, Germany)
- Fasting period: the animals were given no feed 16 h before administration, but water was available ad libitum
- Diet: Kliba Labordiaet 343 (Klingentalmuehle AG, Kaiseraugst, Switzerland), ad libitum
- Water: ad libitum
- Acclimatization period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24 °C
- Humidity: 30-70 %
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5 % aqueous carboxymethylcellulose

Details on dermal exposure:

- Concentration of the test material in vehicle: 50 %
- Amount of test material applied: 4 ml/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

A single application of the test material was applied on the clipped epidermis (dorsal and dorsolateral parts of the trunk), ca 50 cmxcm. The application site was covered with an semiocclusive dressing for 24 hours. Afterward the dressing was removed and the application site was rinsed with warm water.
The signs and symptoms of toxicity were recorded several times on the day of application, at least once each working day. A check for moribund and dead animals was conducted each working day and once on holidays.
30-60 min after removal of the semiocclusive dressing a scoring for skin findings was conducted, and again one week later and before termination of the study.
- The body weights of the individual animals were gathered prior to application of the test material and on day 7 and 13 after dosing.
- Necropsy of survivors performed: Deceased animals and those sacrificed at the end of the observation period (on day 14 after dosing) were necropsied. 16 h before sacrifice the food was withdrawed and the animals were sacrificed with CO2.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

All animals survived, no mortality was observed.

Clinical signs:

other: No clinical signs of toxicity were seen in males or females. A local irritation index could not be read, because of staining due to the colour of the test material in males and females.

Gross pathology:

Autopsy revealed no relevant findings.

Any other information on results incl. tables

Table 1: Mean body weight (g) of rats after dermal application

	Males	Females
Dose level [mg/kg bw]	5000	5000
Day 7	277	207
Day 13	304	218

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU