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Toxicological information

Acute Toxicity: oral

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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

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.