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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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