Glycerides, tall-oil mono-, di-, and tri-

Repeated dose toxicity: dermal

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

Test material information

Constituent 1

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

IUPAC Name:

73398-61-5

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 or test system 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