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Toxicological information

Repeated dose toxicity: dermal

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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:
1980
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
Name:
Unnamed
Type:
Constituent
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.

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