Disulfo copper phthalocyanine amine salt

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Subacute toxicity studies of selected organic colorants

Author:

K.H. Leist

Year:

1982

Bibliographic source:

Ecotoxicology and Environmental Safety (1982), 6(5), 457-63

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

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

Test material information

Constituent 1

Reference substance name:

Disulfo copper phthalocyanine amine salt

EC Number:

215-523-1

EC Name:

Disulfo copper phthalocyanine amine salt

Cas Number:

1328-51-4

Molecular formula:

C32H14CuN8O6S2.2Na

IUPAC Name:

Disulfo copper phthalocyanine amine salt

Test material form:

solid

Details on test material:

- Name of test material: Disulfo copper phthalocyanine amine salt
- Molecular formula: C32 H14 Cu N8 O6 S2.2Na
- Molecular weight: 780.1706 g/mol
- Smiles notation: c1ccc\2c(c1)/c/3n/c-4n/c(n\c5c6c(cccc6S(=O)(=O)[O-])c/7n5[Cu]n3/c2n\c-8n/c(n7)/c9c8c(ccc9)S(=O)(=O)[O-])/c1c4cccc1.[Na+].[Na+]
- InChl: 1S/C32H16N8O6S2.Cu.2Na/c41-47(42,43)21-13-5-11-19-23(21)31-37-27-17-9-3-1-7-15(17)25(34-27)33-26-16-8-2-4-10-18(16)28(35-26)38-32-24-20(30(40-32)36-29(19)39-31)12-6-14-22(24)48(44,45)46;;;/h1-14H,(H2-2,33,34,35,36,37,38,39,40,41,42,43,44,45,46);;;/q-2;+2;2*+1/p-2
- Substance type: Organic
- Physical state: solid

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

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

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

Results and discussion

Preliminary study:

No data available

Effect levels

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:

other: No signs of toxicity were observed in treated rats at 5000 mg/kg bw

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

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.