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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documented, scientifically acceptable study report. Non GLP, minor deviations according to current OECD 404 guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

8 day observation period, exposure of intact and abraded skin for 24h, scoring after 24h, 72h and 8 days

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: according to Federal Register 38 , No. 187, § 1500.41 , p. 27029 of Sep. 27, 1973 (Draize test)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)

EC Number:

288-107-0

EC Name:

Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)

Cas Number:

85650-96-0

IUPAC Name:

85650-96-0

Details on test material:

- Molecular weight (if other than submission substance): 925
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: blue solid
- Physical state: solid
- Analytical purity: commercial grade
- Impurities (identity and concentrations):
- Stability under test conditions: stable

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

Mean body weight: males 2.97 kg, female 2.85 kg
The animals were offered a standardized animal laboratory diet.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: intact and abraded skin

Vehicle:

water

Controls:

other: untreated skin of the animals

Amount / concentration applied:

about 0.5 g of a 50% test substance preparation

Duration of treatment / exposure:

24 hours

Observation period:

8 days

Number of animals:

3

Details on study design:

Application area: 2.5 x 2.5 cm
Application site: back
The test substance was not washed off.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: intact skin; only one animal with finding(s)

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.8

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

other: abraded skin

Irritant / corrosive response data:

Erythema score (intact and abraded skin) could not be read due to substance-induced coloration.

Any other information on results incl. tables

Table 1: Results

Animal No.		1	2	3	Mean
Animal weight (kg)		3.11	2.83	2.85
Sex		Male	Male	Female
Erythema lntact skin	24h	A	A	A
	72h	A	A	A
	8 d	0	0	0
Erythema Abraded Skin	24 h	A	A	A
	72h	A (S)	A(S)	A(S)
	8 d	0 (S)	0 (S)	0 (S)
Edema	24 h	2	0	0	0.7
	72 h	0	0	0	0.
	8 d	0	0	0
Edema Abraded Skin	24 h	2	1	1	1.3
	72 h	0	1	0	0.3
	8 d	0	0	0

A= irritation index could not be read due to substance -induced coloration

S = scaling

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU