Registration Dossier

Administrative data

Endpoint:
chronic toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study predates GLP and OECD guideilnes, published in peer-reviewed literature, restrictions in design and reporting, but contributing to the overall assessment.

Data source

Reference
Reference Type:
publication
Title:
Lack of toxicity and carcinogenicity of some commonly used cutaneous agents
Author:
Stenbäck F, Schubik P
Year:
1974
Bibliographic source:
Toxicology and Applied Pharmacology, 30, 7-13

Materials and methods

Principles of method if other than guideline:
0.02 ml of the test substance (neat, 50% and 10% solution in acetone) were dropped on the dorsal skin between the flanks of 50 mice/group twice a week on a 1-inch square area which was shaved regularly. The animals were checked weekly, and all lesions and tumors were recorded. Animals were allowed to die spontaneously or were killed when moribund. Complete autopsies were performed on all animals. The skin from all animals, all grossly observed tumors and other lesions in the lungs, livers, kidneys etc., from treated as well as control groups were studied histologically.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Propylene glycol.
Used as obtained from the manufacturer.

Test animals

Species:
mouse
Strain:
Swiss
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Eppley colony
- Age at study initiation: 7 weeks
- Housing: in plastic cages with commercial bedding, 10/cage
- Diet: commercal diet, ad libitum
- Water: libitum

Administration / exposure

Type of coverage:
open
Vehicle:
acetone
Details on exposure:
TEST SITE
- Area of exposure: 1-inch square
- % coverage: 0
- Type of wrap if used: none
- Time intervals for shavings or clipplings: regularly


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.02 ml
- Concentration (if solution): 100, 50 and 10%
- Constant volume used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.02 ml
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Lifespan
Frequency of treatment:
Twice a week
Doses / concentrations
Remarks:
Doses / Concentrations:
10%, 50% and 100% in 0.02 ml acetone
Basis:

No. of animals per sex per dose:
50 females/dose
Control animals:
other: 135 untreated animals served as controls, 50 animals were treated with the solvent alove; 50 were treated with 7,12-dimethylbenzanthracene as a positive control
Details on study design:
- Rationale for animal assignment (if not random): the animals were randomized prior to the start of the experiments; the littermates were separated.
Positive control:
7,12-dimethylbenzanthracene

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: weekly; all lesions and tumors were recorded.
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes. The skin from all animals, all grossly observed tumors and other lesions in the lungs, livers, kidneys etc. from treated as well as control groups were studied histologically.
Statistics:
The statistical significance of the results was evaluated using the methods presented by Armitage (1971).

Results and discussion

Results of examinations

Clinical signs:
not specified
Dermal irritation:
not specified
Mortality:
not specified
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
no effects observed
Details on results:
No substance-related tumor increases were evidenced in mice treated with monopropylene glycol at different concentrations.

Effect levels

Dose descriptor:
NOAEL
Effect level:
0.02 other: ml/twice a week
Sex:
female
Basis for effect level:
other: No substance-related tumor increases were evidenced with neat monopropylene glycol.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion