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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
The effects of applications of various substances on the epidermis of the rat.
Author:
Butcher, E.
Year:
1950
Bibliographic source:
The Journal of Investigative Dermatology (1951) 16: 85–90

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
daily application for 5 - 14 days, the clipped back of the rats was swabbed with the test subtance
GLP compliance:
no
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
204-007-1
EC Name:
Oleic acid
Cas Number:
112-80-1
Molecular formula:
C18H34O2
IUPAC Name:
octadec-9-enoic acid
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
other: Long Evans and Albino
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 22 days and older
- Housing: single housing
- Diet: Purina chow

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: back

TEST MATERIAL
- Amount(s) applied: the skin was swabbed with an unspecified amount of test substance
- Constant volume or concentration used: yes

USE OF RESTRAINERS FOR PREVENTING INGESTION: no data
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
once daily for 5 days to two weeks
Frequency of treatment:
daily
No. of animals per sex per dose:
no data
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: No data

DETAILED CLINICAL OBSERVATIONS: No
only skin is examined

DERMAL IRRITATION: Yes
- Time schedule for examinations: After the applications small areas of skin were taken for microscoplical anlysis, the treated skin of the living animals was further observed and biopsies conducted.

BODY WEIGHT: No

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No

WATER CONSUMPTION: No

OPHTHALMOSCOPIC EXAMINATION: No

HAEMATOLOGY: No

CLINICAL CHEMISTRY: No

URINALYSIS: No

NEUROBEHAVIOURAL EXAMINATION: No

Sacrifice and pathology:
GROSS PATHOLOGY: No
HISTOPATHOLOGY: Yes but only the skin was examined

Results and discussion

Results of examinations

Clinical signs:
not examined
Dermal irritation:
effects observed, treatment-related
Mortality:
not examined
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:
not examined
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
The test substance affected the epidermis and also the epithelial lining of the hair follicles. Lymphocytes infiltrated the corium.
Histopathological findings: neoplastic:
no effects observed
Details on results:
HISTOPATHOLOGY: NON-NEOPLASTIC
The test substance affected the epidermis and also penetrated the hair follicles and affected their epithelial lining. Lymphocytes infiltrated the corium.

Effect levels

Dose descriptor:
NOAEL
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion