Reaction product of Chloro[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]aluminium, sulphuric acid and caustic soda

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Maximisation test was done by first applying an irritant to the skin of volunteers. This was followed by an induction phase with the test substance applied at two locations to the volunteers for 48 hours, followed by either a repeat application of the irritant for 24 hours or a rest period of 24 hours. This was repeated up to a total of five induction administrations. Eleven days later, a challenge test was done by administering the test substance to one of the two induced locations.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

EC Number:

307-259-1

EC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Cas Number:

97592-62-6

Molecular formula:

not available

IUPAC Name:

Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

- Name as used in the study report: MA-78 = compound 4204

Method

Type of population:

general

Ethical approval:

other: Study approved by institutional review board of the test facility; informed consent free of coercion received

Subjects:

- Number of subjects exposed: 32; 30 completed the study
- Sex: male and female
- Age: 15-78
- Race: not designated
- Inclusion criteria: Twelve (12) years of age or older. Free of significant systemic or dermatologic disorder. Completing preliminary medical form. Reading, understanding and signing an informed consent.
- Exclusion criteria: Any visible skin disease at the test site which might interfere with the evaluation. Individuals taking medication which in the opinion of the investigators would interfere with the test results. Individuals with atopic dermatitis

Clinical history:

- No visible skin disease at test site which might interfere with the evaluation
- No medication which would interfere with the test results
- No atopic dermatitis

Controls:

One induced location at each volunteer acted as internal control

Route of administration:

dermal

Details on study design:

INDUCTION
The test was initiated with the application of 0.2 ml of 2.5% aqueous sodium lauryl sulfate to duplicate sites on the subjects back. Twenty-four hours later both patches were removed and evaluated. Following evaluation, a patch containing 0.1 ml of test material was applied to one site, while the other (control) was covered with a non-treated patch. Forty-eight hours later both patches were removed and the sites graded. Those sites with at least a 1+ reaction were "allowed to rest" for 24 hours. If no erythema (1+ or more) was present, the sites were again covered with SLS patches for twenty-four hours. This procedure of alternating 24 hour sodium lauryl sulfate (or rest period if 1+ reaction was present) and 48 hours test material patches was continued for a total of five applications of the test material. On Thursday of week 3, a final evaluation of the test sites was made. The panelists were dismissed for an eleven day rest period with instructions to avoid irritating the test sites throughout the recess and to notify the investigator immediately if any adverse changes were observed.

CHALLENGE
On Monday of week 5, occlusive patches containing approximately 0.2 ml. of 5.0% aqueous sodium lauryl sulfate were applied to duplicate sites. After a period of one hour, the patches were removed. As in the induction phase, one site was then covered with an untreated occlusive patch, while the other received a patch containing 0.1 ml of test material. Forty-eight hours later the patches were removed, the area wiped with a tissue and the sites graded at twenty-four hour intervals, i.e., 48, 72 and 96 hours after application. The reactions were graded on a five point scale from - = no reaction to ++++ = vesticular reaction. A grade of ++ (erythema with edema) at the challenged site, without a similar reaction at the control site, was considered to be a sign of sensitisation.

Results and discussion

Results of examinations:

During the challenge phase, one individual showed a + reaction 96 hours after patch application of test material (48 hours after removal of patch). This reaction represents irritancy since (1) the SLS control site had a similar + reaction and (2) a reaction of ++ or greater is generally needed to establish sensitization. Eight subjects had reactions graded as ++ or +++ on the SLS control sites at some time during the induction phase. These reactions had minimal edema and did not spread beyond the site of application. Thus, these scores represent irritant reactions, which was the purpose for using SLS. Similar reactions were seen during induction at product test sites in eight individuals. These were also interpreted as irritant reactions.