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Administrative data

Description of key information

Disulfo copper phthalocyanine amine salt (CAS no 1328-51-4) ) and it’s structurally similar read across Phthalocyanine, metal free is likely to be non hazardous by oral route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer-reviewed journal
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study of Direct Blue 86 in rats
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (as cited in study report): Direct Blue 86 (Disulfo copper phthalocyanine amine salt)
- Molecular formula (if other than submission substance): C32H14CuN8O6S2.2Na
- Molecular weight (if other than submission substance): 780.1706 g/mole
- Substance type: Organic
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
- Other examinations performed: clinical signs were observed
Statistics:
No data available
Preliminary study:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effect on survival and clinical sign
Mortality:
No mortality was observed in treated rats at 5000 mg/kg bw
Clinical signs:
No signs of toxicity were observed in treated rats at 5000 mg/kg bw
Body weight:
No data available
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when rat were treated with Direct Blue 86 (Disulfo copper phthalocyanine amine salt) orally.
Executive summary:

In a acute oral toxicity study,rats were treated with Direct Blue 86 (Disulfo copper phthalocyanine amine salt) in the concentration of 5000 mg/kg bw. No effect on survival and clinical signs of toxicity were observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw whenrat were treated with Direct Blue 86 (Disulfo copper phthalocyanine amine salt) orally.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
Data is Klimisch 2 and from peer-reviewed journal

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity:

In different studies, Disulfo copper phthalocyanine amine salt has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for Disulfo copper phthalocyanine amine salt along with the study available on structurally similar read across substance Phthalocyanine, metal free (CAS no 574-93-6) and pigment blue 15 (CAS no 147-14-8).

In a acute oral toxicity study by Leistet al(Ecotoxicology and Environmental Safety (1982), 6(5), 457-63), rats were treated with Disulfo copper phthalocyanine amine salt in the concentration of 5000 mg/kg bw. No effect on survival and clinical signs of toxicity were observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw whenrat were treated with Disulfo copper phthalocyanine amine salt orally.

In another study by ChemIDplus Toxnet Database (2017), rats were treated with Disulfo copper phthalocyanine amine salt in the concentration of 5000 mg/kg bw. No effect on survival of treated rats were observed at 5000 mg/kg bw. Therefore, LD50 was considered to be > 5000 mg/kg bw when rat were treated with Disulfo copper phthalocyanine amine salt orally.

Also it is further supported experimental data conducted given by Commission of the European Communities (1988) on structurally similar the read across substance Phthalocyanine, metal free (CAS no 574-93-6), rats were treated with Phthalocyanine, metal free in the concentration of 6000 mg/kg bw. No effect on survival were observed in treated rats at 6000 mg/kg bw. Therefore, LD50 was considered to be > 6000 mg/kg bw when rat were treated with Phthalocyanine, metal free orally.

In supporting above similar source for anther structurally similar read across substance pigment blue 15 (CAS no 147-14-8),rats were treated with pigment blue 15 in the concentration of 4600 mg/kg bw. No effect on survival were observed in treated rats at 4600 mg/kg bw. Therefore, LD50 was considered to be > 4600 mg/kg bw when rat were treated with pigment blue 15 orally.

Thus, based on the above studies on Disulfo copper phthalocyanine amine salt (CAS no 1328-51-4) and its structurally similar read across Phthalocyanine, metal free (CAS no 574-93-6) and pigment blue 15 (CAS no 147-14-8), it can be concluded that LD50 value is less than 2000 mg/kg bw. Thus comparing this value with the criteria of CLP regulation, Disulfo copper phthalocyanine amine salt can be “Not classified” for acute oral toxicity.

Justification for classification or non-classification

Based on the above available data for target Disulfo copper phthalocyanine amine salt (CAS no 1328-51-4) and its structurally similar read across Phthalocyanine, metal free (CAS no 574-93-6) and pigment blue 15 (CAS no 147-14-8) is likely to be non hazardous by oral route of exposure.