Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Test for carcinogenicity of food additives and chemotherapeutic agents by the pulmonary tumor response in strain A mice
Author:
Stoner GD et al.
Year:
1973
Bibliographic source:
Cancer Research 33, 3069-3085
Reference Type:
secondary source
Title:
No information
Author:
RIFM
Year:
2009
Bibliographic source:
RIFM database

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
preliminary toxicity study for a following carcinogenicity study
GLP compliance:
no
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Lot/batch No.: Lot 36176
- Source: J.T. Baker Chemical Co., Phillipsburg, NJ

Test animals

Species:
mouse
Strain:
other: A/He
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Institute for Cancer Research, Philadelphia, or obtained from the National Cancer Institute
- Age at study initiation: 6 - 8 w
- Weight at study initiation: 18 - 20 g
- Housing: in groups of 5 in plastic boxes
- Diet (e.g. ad libitum): Purina laboratory chow; ad libitum
- Water (e.g. ad libitum): water; ad libitum

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: tricaprylin
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
2 weeks
Frequency of treatment:
6 times in 2 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 250 mg/kg/bw (nominal conc. dose per application)
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
yes, concurrent vehicle
Details on study design:
- Post-exposure period: 1 - 2 months
- The MTD was the maximum single dose that all 5 mice tolerated after receiving 6 i.p, injections over a 2-week period.

Results and discussion

Effect levels

Dose descriptor:
other: MTD
Effect level:
6 000 mg/kg bw (total dose)
Based on:
test mat.
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion