[No public or meaningful name is available]

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:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: the techniques specified in the Federal Insecticide, Fungicide, and Rodenticide Act (40 CFR 163).

Principles of method if other than guideline:

Five-tenths gram of the undiluted test material moistened with five-tenths milliliter physiological saline was applied on April 7, 1981, 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 J & J Research Farms, Inc.

GLP compliance:

no

Remarks:

GLP not mandatory at this date

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

Test system

Type of coverage:

occlusive

Preparation of test site:

other: two intact skin areas and two abraded skin areas

Vehicle:

other: Moistened with 0.5ml physiological saline

Controls:

no

Amount / concentration applied:

0.5g powder

Duration of treatment / exposure:

24-hour exposure

Observation period:

24 hours, and 72 hours

Number of animals:

6

Details on study design:

Five-tenths gram of the undiluted test material moistened with five-tenths milliliter physiological saline was applied on April 7, 1981, 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 J & J Research Farms, Inc. 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.

At the end of the 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 at 73 to 73 1/4 hours post-dosing (72-hour reading),

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Scoring at 48 hours not performed

Basis:

mean

Time point:

24/48/72 h

Score:

0.17

Reversibility:

not specified

Results 2

Irritation parameter:

edema score

Remarks:

Scoring at 48 hours not performed

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Irritant / corrosive response data:

Irritative effects noted during the cours-e of the study included mild erythema which was observed at abraded or intact sites of five animals. Very slight edema scores were noted in one animal on abraded sites. Most skin irritation was absent by the 72-hour reading. No evidence of corrosivity was found.
The Primary Irritation Index was found to be 0.4.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under tests conditions and based on GHS criteria, the test item is not classified due to the low Primary Irritation Index score (0,4).