Registration Dossier
Registration Dossier
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EC number: 277-452-2 | CAS number: 73398-61-5
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Review, basic data given.
Data source
Reference
- Reference Type:
- publication
- Title:
- Final Report of the Safety Assesment for Caprylic/Capric Triglyceride.
- Author:
- Elder, E.L
- Year:
- 1 980
- Bibliographic source:
- J. Environ. Pathol. Toxicol.(4):105-120
Materials and methods
- Principles of method if other than guideline:
- A perfumed skin softner formulation containing 4% Caprylic/Capric Triglyceride was applied to shaved skin of 15 female rats at a dose of 2 mL/kg five days a week for 13 weeks.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Glycerides, mixed decanoyl and octanoyl
- EC Number:
- 277-452-2
- EC Name:
- Glycerides, mixed decanoyl and octanoyl
- Cas Number:
- 73398-61-5
- Molecular formula:
- C27H50O6 to C33H62O6
- IUPAC Name:
- Glycerides, mixed decanoyl and octanoyl
- Details on test material:
- - Name of test material (as cited in study report): Caprylic/Capric Triglyceride
A perfumed skin softener formulation containing 4% Caprylic/Capric Triglyceride was used for topical application.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on exposure:
- TEST SITE
- Area of exposure: Applied to shaved skin - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily on five days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2 mL/kg bw/d (of a 4% Caprylic/Capric Triglyceride containing formulation)
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
75.6 mg/kg bw/d
Basis:
other: calculated using a density of 945 mg/mL and 4% substance as such
- No. of animals per sex per dose:
- 15
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
DERMAL IRRITATION (if dermal study): Yes
BODY WEIGHT: Yes
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs and mortality observed
BODY WEIGHT AND WEIGHT GAIN
No effect on body weight.
HAEMATOLOGY
All blood cells were normal.
CLINICAL CHEMISTRY
Serum chemistry parameters measured one week before termination of the study were within normal limits and comparable to those seen in an equal group at controls.
ORGAN WEIGHTS
No effect on the organ weights.
GROSS PATHOLOGY
No gross pathology findings were observed.
HISTOPATHOLOGY: NON-NEOPLASTIC
No histopathological changes were observed.
OTHER FINDINGS: There were no localized effects on the skin.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 75 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- female
- Basis for effect level:
- other: body weight, clinical signs, several blood-cell and serum chemistry parameters, organ weights, gross and histopathological examination.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 875 mg/kg bw/day
- Based on:
- test mat.
- Remarks:
- (4% formulation)
- Sex:
- female
- Basis for effect level:
- other: body weight, clinical signs, several blood-cell and serum chemistry parameters, organ weights, gross and histopathological examination.
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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