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Toxicological information

Skin sensitisation

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 group
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.