Glycerides, C8-18

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 Jun - 01 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Principles of method if other than guideline:

Comedogenicity study in rabbits

GLP compliance:

yes

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C8-18

EC Number:

287-487-5

EC Name:

Glycerides, C8-18

Cas Number:

85536-06-7

Molecular formula:

Not applicable: Complex UVCB substance

IUPAC Name:

Glycerides, C8-18 (even numbered)

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: ivory cream
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ, USA
- Weight at study initiation: 3.3 kg (male), 3.2 and 3.6 kg (females)
- Housing: individual caging in suspended stainless steel cages with mesh floor
- Diet: Pelleted Purina Rabbit Chow, ad libitum
- Water: tap water supplied by automatic water system
- Acclimation period: 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.8-21.1

Administration / exposure

Route of administration:

dermal

Vehicle:

unchanged (no vehicle)

Details on exposure:

TEST SITE
- Area of exposure: internal base of the left ear

TEST MATERIAL
- Amount applied: not specified; the test material was applied with a glass rod to ensure complete coverage of the test site.

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

3 weeks

Frequency of treatment:

daily, 5 days/week

Post exposure period:

No post-exposure period

No. of animals per sex per dose:

1 male, 2 females

Control animals:

other: the untreated ear of the same animal served as negative control

Examinations

Examinations:

BODY WEIGHT

Body weights were recorded prior to testing and at terminal sacrifice.

EVALUATION OF COMEDOGENICITY

- Macroscopic evaluation

Prior to each application, the test site and the negative control ear were scored for hyperkeratosis and comedone formation according to the following "in vivo and histological comedogenicity scoring scale" (Fulton et al., 1976. Non-comedogenic cosmetics. Cutis 17:344-351):

Score 0: no increase in visible follicular hyperkeratosis
Score 1: an increase in visible hyperkeratosis
Score 2: an increase in visible hyperkeratosis extending to the possible presence of comedones
Score 3: significant comedones
Score 4: significant comedones
Score 5: severe lesions

- Microscopic evaluation

After the last macroscopic evaluation, the rabbits were sacrificed and the ears were excised, preserved in 10% buffered formalin and prepared for histological examination for the presence of comedones.

Results and discussion

Details on results:

OBSERVATIONS

All animals appeared active and healthy during the test period. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

BODY WEIGHT

All animals gained weight.

EVALUATION OF COMEDOGENICITY

Slight hyperkeratosis was observed on the treated ears during the 3-week dosing period. The control ears were clear.

Histological scores were 2 for all treated ears and 0 for all controls. This indicated the presence of hyperkeratosis and some resultant keratin material in the follicles. The presence of follicular comedones was not noted.

Applicant's summary and conclusion

Conclusions:

The test substance causes follicular hyperkeratosis but does not cause comedone formation after being applied neat, 5 days/week for 3 consecutive weeks.