Registration Dossier
Registration Dossier
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EC number: 271-685-3 | CAS number: 68604-33-1 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid ammonium salt and SDA Reporting Number: 04-006-01.
Repeated dose toxicity: dermal
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:
- other: Publication on non-guideline study, no precise dose concentration given, classification on the basis of these results is not possible.
Data source
Reference
- Reference Type:
- publication
- Title:
- The effects of applications of various substances on the epidermis of the rat.
- Author:
- Butcher, E.
- Year:
- 1 950
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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