[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Molecular formula:

C32H16N8Co(SO3)n with n=0 to 3

IUPAC Name:

Reaction mass of Trihydrogen [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cobaltate(3-) and [29H,31H-phthalocyaninato-N29,N30,N31,N32]cobalt and dihydrogen [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cobaltate(2-) and hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cobaltate(1-)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

The rabbits were individually identified by means of numbered ear tags. The rabbits were acclimated to the laboratory for 27 days before dosing.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Details on dermal exposure:

The dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers. The abdominal skin area of all of the rabbits iri each group was abraded by making a series of longitudinal minor epidermal incisions placed two to three centimeters apart, using a hypodermic needle as a cutting tool. The abrasions were sufficiently deep to penetrate the epidermis, but not to induce bleeding. The undiluted sample was moistened with 4 milliliters of physiological saline and applied at a dosage level of 2.0 g/kg of body weight. The test sample was kept in contact with the skin on at least 1056 of the body surface. The sample was placed in a sleeve of rubber dental damming in which a pocket had been formed to furnish a reservoir for the dose. The dental damming was wrapped around the trunk of the animal and secured with staples. An outer layer of gauze was placed around the trunk of the animal. The rabbit was restrained for approximately 23 1/2 to 23 3/4 hours in a Newmann harness.

Duration of exposure:

24h

Doses:

2g/ kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

During the exposure each rabbit was observed for signs of toxicity at approximatelyone, two, four, and twenty-one hours post-application. The observation at 21 hours was not prescribed in the protocol.
At the end of the exposure period the binder was removed and any unabsorbed sample remaining on the s^in was removed by gentle sponging with a moistened towel. Each rabbit was examined thoroughly for gross signs of systemic toxicity and dermal irritation.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortalities occurred during the course of the study.

Clinical signs:

other: Erythema and edema, followed by desquamation and sometimes atonia were seen at the application site in each animal. Most effects ranged from mild to marked in severity. Scar tissue was observed in eight animals during the second week of observations.

Gross pathology:

Gross necropsies performed upon the termination of the study revealed two rabbits (Nos. 3 and 8) with pitted kidneys. Gas in the intestine of two rabbits (Nos. 3 and 7) was also noted. These findings were not considered drug-related. No other gross changes were found.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD value of Cobalt Phthalocyanine Sulfonate was found to be greater than 2.0 g/Kg of body weight for New Zealand White rabbits.
Irritative effects noted during the study included desquamation, atonia, erythema, spotted whitening, edema, and scar tissue on abrasions. No systemic effects were found. None of the animals died.

Under tests conditions, test item do not required classification according to GHS criteria.