Disulfo copper phthalocyanine amine salt

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source.

Data source

Reference

Reference Type:

secondary source

Title:

Reports of the Scientific Committee on Cosmetology (seventh series)

Author:

Commission of the European Communities

Year:

1988

Bibliographic source:

Directorate-General Environment, Consumer Protection and Nuclear Safety- Commission of the European Communities- Brussels Luxembourg, 1988.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

The skin sensitization study of Pigment Blue 15 was conducted on guinea pigs to determine its sensitization potential.

GLP compliance:

not specified

Type of study:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pigment Blue 15

IUPAC Name:

Pigment Blue 15

Constituent 2

Reference substance name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

EC Number:

205-685-1

EC Name:

29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper

Cas Number:

147-14-8

Molecular formula:

C32H16CuN8

IUPAC Name:

[29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report):Copper, (29H,31H-phthalocyaninato(2-)-N(29),N(30),N(31),N(32)
- Molecular formula (if other than submission substance):32H16CuN8
- Molecular weight (if other than submission substance):578.0962 g/mol
- Smiles notation (if other than submission substance):c1ccc2=C3N=C4c5ccccc5C6=N4[Cu+2]78[N-]3C(=c2c1)N=C9N7=C(c1c9cccc1)N=C1[N-]8C(=N6)c2c1cccc2
- Substance type:Organic
- Physical state:no data

Specific details on test material used for the study:

Name of test material (as cited in study report):Copper, (29H,31H-phthalocyaninato(2-)-N(29),N(30),N(31),N(32), Copper phthalocyanine
- Molecular formula :C32H16CuN8
- Molecular weight :578.0962 g/mol
- Smiles notation :c1ccc2=C3N=C4c5ccccc5C6=N4[Cu+2]78[N-]3C(=c2c1)N=C9N7=C(c1c9cccc1)N=C1[N-]8C(=N6)c2c1cccc2
- Substance type:Organic

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

water

Concentration / amount:

1% aqueous solution(0.1mL)

Day(s)/duration:

5 days

Challenge

Route:

other: epicutaneous

Vehicle:

water

Concentration / amount:

1% aqueous solution(0.1mL)

No. of animals per dose:

no data

Details on study design:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:15
- Exposure period:5 days
- Test groups: guinea pigs
- Control group: no data
- Site: no data
- Frequency of applications: 3 times/day
- Duration: :5 days
- Concentrations: 1% aqueous solution(0.1mL)

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: after 4 weeks
- Exposure period: no data
- Test groups: guinea pigs
- Control group: no data
- Site: no data
- Concentrations: 1% aqueous solution(0.1mL)
- Evaluation (hr after challenge): no data
OTHER:

Challenge controls:

no data

Positive control substance(s):

not specified

Study design: in vivo (LLNA)

Statistics:

No data available.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

672

Group:

test chemical

Dose level:

1% aqueous solution(0.1mL)

No. with + reactions:

0

Clinical observations:

not sensitising

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

not specified

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

The skin sensitization study of Pigment Blue 15 (CAS No: -147-14-8) was performed in guinea pigs to observed its sensitizing efficacy. The test material Pigment Blue 15 (CAS No: -147-14-8) was observed to be not sensitizing to guinea pigs.

Executive summary:

The skin sensitization study of Pigment Blue 15 (CAS No: -147-14-8) was performed in guinea pigs to observed its sensitizing efficacy.

 

Guinea pigs were induced with intracutaneous injections of a 0.1 mL 1% aqueous solution 3 times/day for 5 days.

 

After 4 weeks, animals were topically challenged with 0.1 mL of 1% aqueous solution.

 

Since guinea pigs did not show any cutaneous reaction, the test materialPigment Blue 15 (CAS No: -147-14-8) was found to be non sensitizing.