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Toxicological information

Acute Toxicity: other routes

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Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
secondary literature

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1993

Materials and methods

Principles of method if other than guideline:
No data given.
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Pigment Blue 15
- Analytical purity: no data given

Test animals

Species:
rat
Strain:
other: albino rats
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
DMSO
Doses:
3000 mg/kg bw
No. of animals per sex per dose:
No data given.
Control animals:
not specified
Details on study design:
No data given.

Results and discussion

Mortality:
No information was given regarding mortality of the animals.
Clinical signs:
The authors of the publication reported the following clinical signs:
- A reduction of diuresis (test -2.1 +- 0.19 ml, control -7.3 +- 0.6 ml) and an increasing of the protein content in urea (test 2.3 +- 0.19 mg/ml, control 1.86 +- 0.07 mg/ml) was seen.
- No test substance or the products of its metabolism were found in the blood.
- The increasing of Cu2+ content in the blood serum of the test animals (in test 1.80+-0.08 mg/ml, in control 1.60+-0.02 mg/ml) was connected with the content of up to 0.2% of the soluble copper salts in the pigment, and was reversible after removing the Cu2+ impurity.

Applicant's summary and conclusion

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