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

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No positive control tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Remarks:

Study pre-dates GLP regulations

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study performed before the LLNA guidelines were published.

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 used in the study report: FAT 60'149/B
- Batch number: Partie 1

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Pirbright white

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: approximately 10 weeks
- Weight at study initiation: 300-400 g
- Housing: individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 830, Gossau SG, supplemented with fresh carrots
- Water: ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 ± 5
- Photoperiod (hrs dark / hrs light): 10/14

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

other: intradermal: saline, and adjuvant and saline; epicutaneous: vaseline phH VI

Concentration / amount:

- intradermal application: 0.1% ; 0.1 mL per injection
- epicutaneous application: 30%

Day(s)/duration:

7 days after the intradermal application, the substance was applied epicutaneous for 48 hours.

Adequacy of induction:

other: The concentrations of the test compound for the induction and challenge periods were determined on separate animals before starting the test procedure.

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: soft white paraffin

Concentration / amount:

30%

Day(s)/duration:

24 hours

Adequacy of challenge:

other: The concentrations of the test compound for the induction and challenge periods were determined on separate animals before starting the test procedure.

No. of animals per dose:

20

Details on study design:

Test procedure
The concentrations of the test compound for the induction and challenge periods were determined on separate animals before starting the test procedure. A control group was treated with the vehicles alone (negative control).

INDUCTION, INTRADERMAL:
Two intradermal injections (0.1 ml per injection) were made into the nape of the guinea pigs with a mixture of adjuvant and saline, with the test compound in saline and with the test compound in the adjuvant saline mixture.

INDUCTION, EPIDERMAL:
One week later the test substance was incorporated in soft white paraffine and applied on a filterpaper patch to the nape of the animals (occlusive administration for 48 hours). Twenty-four hours before the compound application the induction site was treated epidermal open with 10 % sodium lauryl sulphate in vaseline.

CHALLENGE:
Two weeks after the epidermal induction application the animals were tested on one flank with 30 % FAT 60'149/B in soft white paraffine (24 h occlusive application). Twenty-four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet , 5 minutes).

Challenge controls:

A control group was treated with the vehicles alone (negative control).

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

30%

No. with + reactions:

0

Total no. in group:

20

Results 2

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

30%

No. with + reactions:

0

Total no. in group:

20

Any other information on results incl. tables

None of the animals of the test or control group reacted after epidermal occlusive challenge application.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met