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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: A sensitization test in guinea pigs
Deviations:
not specified
Principles of method if other than guideline:
A sensitization test in guinea pigs
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
The non-LLNA study was performed prior to the widespread validation of this LLNA assay.
Further animal testing is not justifed.

Test material

Constituent 1
Chemical structure
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:
solid: crystalline

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: intracutaneous injections
Vehicle:
other: aqueous solution
Concentration / amount:
0.1 ml 1% aqueous solution
Day(s)/duration:
5
Adequacy of induction:
not specified
Challenge
Route:
other: topical challenge treatment, epicutaneous
Vehicle:
other: aqueous solution
Concentration / amount:
0.1 ml 1% aqueous solution
Day(s)/duration:
4 weeks
Adequacy of challenge:
not specified
No. of animals per dose:
not specified
Details on study design:
In a sensitization test, guinea pigs received intracutaneous injections of
0.1 mL 1% aqueous solution, 3 times daily for 5 consecutive days. After a
rest period of 4 weeks 0.1 ml 1% aqueous solution administered again
intracutaneously
Challenge controls:
not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
120
Group:
test chemical
Dose level:
0.1 ml 1% aqueous solution
No. with + reactions:
0
Total no. in group:
15
Clinical observations:
A sensitization test in guinea pigs with induction treatment by intracutaneous injections of a 0.1 ml 1% aqueous solution 3 times/day for 5 days, and topical challenge treatment with 0.1 ml 1% aqueous solution after 4 weeks was negative.
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
120
Group:
negative control
Remarks on result:
other: No information available
Reading:
1st reading
Hours after challenge:
120
Group:
positive control
Remarks on result:
other: No information available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A sensitization test in guinea pigs with induction treatment by intracutaneous injections of a 0.1 ml 1% aqueous solution of CuPC 3 times/day for 5 days, and topical challenge treatment with 0.1 ml 1% aqueous solution after 4 weeks was negative. In a sensitization test, guinea pigs received intracutaneous injections of 0.1 mL 1% aqueous solution, 3 times daily for 5 consecutive days. After a rest period of 4 weeks 0.1 ml 1% aqueous solution administered again intracutaneously produced a slight positive reaction in 5/15 test animals.