Lanolin, hydroxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

13 April1987 to 1 May 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- Principle of test: Comedogenicity Assay
- Short description of test conditions: After a 6 day adaptation period, 6 uniquely identified rabbits were treated with the test material as a 6% w/w
solution in cottonseed oil. The test material was applied to the internal base of the right ear of each animal daily on 5 consecutive days per week for 3 weeks. The left ear was treated with cottonseed oil only and served as the positive control. The test material was applied at approximately the same time each day in a manner to ensure complete coverage of the test site.
- Parameters analysed / observed: Prior to each application, the test site and the positive control ear were scored for hyperkeratosis and comedone formation according to the in vivo Comedone scoring scale.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin, hydroxylated

EC Number:

270-315-8

EC Name:

Lanolin, hydroxylated

Cas Number:

68424-66-8

IUPAC Name:

Lanolin, hydroxylated

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Summit View Farms, Belvidere, NJ
- Age at study initiation:
- Weight at study initiation:
- Housing: individually in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow ad-libitum.
- Water (e.g. ad libitum): Tap water supplied by automatic water system
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-84°C.
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

other: Cottonseed oil

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 6% w/w solution in cottonseed oil

Duration of treatment / exposure:

The test material was applied to the internal base of the right ear of each animal daily on 5 consecutive days per week for 3 weeks.

Observation period:

None, all animals were sacrificed after the last evaluation.

Number of animals:

Six rabbits (6 male, 0 female)

Details on study design:

TEST SITE
- Area of exposure: internal base of the right ear
- % coverage: N/A
- Type of wrap if used: None

REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
- Time after start of exposure: N/A

OBSERVATION TIME POINTS
Prior to each application, the test site and the positive control ear were scored for hyperkeratosis and comedone formation.

SCORING SYSTEM:
- Method of calculation: Degree of Comedone Formation
Score Deqree of Comedone Formation
0 No increase in visible follicular hyperkeratosis
1 An increase in visible hyperkeratosis
2 An increase in visible hyperkeratosis extending to the possible presence of comedones
3 Significant comedones
4 Significant comedones
5 Severe lesions

Results and discussion

In vivo

Results

Irritation parameter:

other: Comedone score

Basis:

mean

Time point:

other: 20 days

Score:

0.4

Max. score:

5

Reversibility:

not specified

Remarks on result:

other: Non-Comedogenic as a 6% w/w solution in cottonseed oil.

Irritant / corrosive response data:

SUMMARY OF DATA
IN-LIFE
Average Comedone Score: 0.4 test solution; 0.08 control.
Number of Comedones at termination: 0 test solution; 0 control.

HISTOLOGY:
Average Comedone Score: 0.9 test solution; 0.5 control.
Number of Comedones: 0 test solution; 0 control.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The Comedogenicity Assay was conducted using the test substance as a 6% w/w solution in cottonseed oil. Based on the average in-life and histological scores, the test material, was considered to be non-comedogenic.

Executive summary:

The Comedogenicity Assay was conducted using the test substance as a 6% w/w solution in cottonseed oil. The right ear of six young adult New Zealand White rabbits were treated with the test material and the left ear was dosed with cottonseed oil (positive control) on 5 consecutive days per week for 3 consecutive weeks. The ears were scored for hyperkeratosis and comedone formation each day prior to application of the test material. At termination, the control and treated ears were excised and subsequently subjected to histological examination for comedones.

All rabbits appeared active and healthy throughout the test period. All gained weight. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Transient, mild hyperkeratosis (scores 1-2) was noted during the second and third weeks of dosing. The average "in-life" scores for the test and control ears were 0.19 and 0.16, respectively. The total number of visible comedones at test termination was zero for treated and control ears. Histological examination showed that all ears (treated and control) were negative with respect to comedone formation although hyperkeratosis with scores of 1-2 was noted in all but one treated section and in 6 out of 12 control sections. The average group histology scores for treated and control ears were 1.1 and 0.5, respectively. The total number of comedones identified histologically was zero for both treated and control ears. Based on the average in-life and histological scores, the test material, applied as a 6% w/w solution in cottonseed oil, is considered to be non-comedogenic.