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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:
migrated information: read-across based on grouping of substances (category approach)
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 study was conducted with a tanning butter formulation containing 22% Caprylic/Capric Triglyceride, which was applied to the clipped backs of rabbits at a dose of 2000 mg/kg five times per week for four 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 tanning butter formulation containing 22% Caprylic/Capric Triglyceride was used for topical application.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
No data

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on exposure:
TEST SITE
- Area of exposure: Applied to the backs of the animals
At weekly intervals the backs of three of these animals and of three controls were abraded through the stratum corneum, leaving the dermis intact.
The backs of the other three test rabbits and of the six controls were not abraded.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 weeks
Frequency of treatment:
Five times a week
Doses / concentrations
Remarks:
Doses / Concentrations:
2000 mg/kg bw/d
Basis:
nominal per unit body weight
No. of animals per sex per dose:
3 males and 3 females
Control animals:
yes
Details on study design:
No data

Examinations

Observations and examinations performed and frequency:
DETAILED CLINICAL OBSERVATIONS: Yes

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes

HAEMATOLOGY: Yes, hematocrit, hemoglobin, cell counts

CLINICAL CHEMISTRY: Yes, blood urea nitrogen, AP, GPT, blood-glucose

Sacrifice and pathology:
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Description (incidence and severity):
slight to moderate erythema
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
Description (incidence and severity):
no effects on hematocrit, hemoglobin concentration and cell counts
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
no effects on the following blood parameters: urea nitrogen, alkaline phosphatasae or glutamic pyruvic transaminase activites, or glucose concentration
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 effects on the physical appearance and behaviour. Also no mortalities were observed.

BODY WEIGHT AND WEIGHT GAIN
No effects attributable to the treatment were noted on body weight.

HAEMATOLOGY
Blood samples taken 23 days after initiation of the test showed no effects on hematocrit, hemoglobin concentration and cell counts.

CLINICAL CHEMISTRY
Blood samples taken 23 days after initiation of the test showed no effects urea nitrogen, alkaline phosphatasae or glutamic pyruvic transaminase activites, or glucose concentration.

GROSS PATHOLOGY
At the end of the test no gross changes referable to the test material were observed.

HISTOPATHOLOGY: NON-NEOPLASTIC
At the end of the test no histopathologic changes referable to the test material were observed.

OTHER FINDINGS: On the treated area of the skin there was slight to moderate erythema and slight peeling and cracking regardless of whether the skin was abraded or left intact.

Effect levels

Dose descriptor:
NOAEL
Effect level:
2 000 mg/kg bw/day
Based on:
other: 22% formulation
Sex:
male/female
Basis for effect level:
other: clinical signs; mortality; body weight; haematology; clinical chemistry; gross pathology; organ weights; histopathology;

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion