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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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