Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Section 163.81 of the Regulations for the Enforcement of the Federal Insecticide, Fungicide, and Rodenticide Act (Federal Register, Wednesday, June 25, 1975).

Principles of method if other than guideline:

Application under a one-inch square surgical gauze patch, two layers thick, to two intact skin areas and two abraded skin areas on each of the six New Zealand White rabbits- Principle of test:
At the end of the 24-hour exposure period, the patches were removed and any residual sample was gently sponged from the skin with a moistened towel.
The reactions were scored immediately after removal of the patches (24-hour reading), and again two days later (72-hour reading),

GLP compliance:

no

Remarks:

Guideline nGLP not mandatory at this date

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

EC Number:

238-200-7

EC Name:

Tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Cas Number:

14285-59-7

Molecular formula:

C32H16CoN8O12S4

IUPAC Name:

tetrahydrogen [29H,31H-phthalocyanine-2,9,16,23-tetrasulphonato(6-)-N29,N30,N31,N32]cobaltate(4-)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Six New Zealand White rabbits from Plunmer's Rabbit Ranch.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: 2 abraded skin and 2 intact skin

Vehicle:

other: Moistened with physiological saline

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24-hour exposure

Observation period:

24h and 72h

Number of animals:

6

Details on study design:

Five-tenths gram of the undiluted test material was moistened with physiological saline and applied under a one-inch square surgical gauze patch, two layers thick, to two intact skin areas and two abraded skin areas on each of the six New Zealand White rabbits from Plunmer's Rabbit Ranch. The rabbits were acclimated to the laboratory for at least 4 days before they were dosed. The rabbits were individually identified by means of numbered ear tags. The application sites were prepared by clipping the hair from the saddle area of the rabbits. The abraded areas were prepared by making minor epidermal incisions with a hypodermic needle. The abrasions were sufficiently deep to penetrate the epidermis, but not to induce bleeding. Each patch was held in place with two strips of one-inch adhesive tape. After application of the patches, the trunk of each rabbit was
wrapped with rubber dental damming, which was secured with staples. An outer layer of gauze and tape was placed around the trunk of each animal. The animals were restrained in Newmann harnesses for 24 hours.
At the end of the 24-hour exposure period, the patches were removed and any residual sample was gently sponged from the skin with a moistened towel.
The reactions were scored immediately after removal of the patches (24-hour reading), and again two days later (72-hour reading), according to the scale reproduced in Table 4 accompanying this report.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

For intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Max. score:

0.5

Reversibility:

not specified

Remarks on result:

other: 48h not assessed

Remarks:

48h not assessed, scoring at 48 hours not performed

Results 2

Irritation parameter:

edema score

Remarks:

For intact skin

Basis:

mean

Time point:

24/48/72 h

Score:

0.04

Max. score:

0.25

Reversibility:

not specified

Remarks on result:

other: 48h not assessed

Remarks:

48h not assessed, scoring at 48 hours not performed

Irritant / corrosive response data:

Irritative effects noted at the 24-hour reading included very slight erythema at three intact and five abraded sites. Very slight edema was noted at one intact site and two abraded sites at the 24-hour reading.
Irritative effects noted at the 72-hour reading were limited to very slight erythema at one intact site.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following a 24-hour patch application of Cobalt Phthalocyanine Tetrasulfonate to the intact and abraded skin areas on the back of New Zealand White rabbits, the Primary Irritation Index was found to be 0.25.

Under tests conditions, results are considered scientifically valid to support a non classification according to GHS criteria.