Registration Dossier

Administrative data

Endpoint:
repeated dose toxicity: other route
Remarks:
other: no data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Toxicological Evaluation of some Food Colours, Enzymes, Flavour Enhancers, Thickening Agents and Certain Food Additives
Author:
WHO
Year:
1974
Bibliographic source:
WHO Food Additives Series, 1974, No.6.

Materials and methods

Principles of method if other than guideline:
Twelve rats received subcutaneous injections of 2 ml of a 2.5 % aqueous suspension of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Indanthrene Blue RS
No further data.
Specific details on test material used for the study:
- Name of test material (as cited in study report): Indanthrenene blue RS
No further data.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
not specified
Remarks:
2.5 % in an aqueous solution
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
no data
Frequency of treatment:
monthly
Doses / concentrations
Remarks:
Doses / Concentrations:
2.5%
No. of animals per sex per dose:
12
Control animals:
not specified

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Six rats survived for 417 - 570 days. No tumours were seen at the site of injection.

Applicant's summary and conclusion