Lanolin, hydroxylated

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Type of study / information:

Comedogenicity Assay -

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

Results and discussion

Any other information on results incl. tables

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.

COMODOGENESIS SCORES

Rabbit No.	7324		7325		7326		7327		7328		7329
Sex	Male		Male		Male		Male		Male		Male
Week	Treated	Control	Treated	Control	Treated	Control	Treated	Control	Treated	Control	Treated	Control
Week 1
Day 1	0	0	0	0	0	0	0	0	0	0	0	0
Day 2	0	0	0	0	0	0	0	0	0	0	0	0
Day 3	0	0	0	0	0	0	0	0	0	0	0	0
Day 4	0	0	0	0	0	0	0	0	0	0	0	0
Day 5	0	0	0	0	0	0	0	0	0	0	0	0
Week 2
Day 1	1	0	0	0	1	0	0	0	1	0	0	0
Day 2	0	0	0	0	0	0	1	0	0	0	0	0
Day 3	0	0	0	0	0	0	0	0	1	0	0	0
Day 4	0	0	0	0	0	0	0	0	0	0	0	0
Day 5	0	0	0	0	0	0	0	0	0	0	0	0
Week 3
Day 1	0	2	0	0	0	0	0	0	1	1	0	0
Day 2	0	2	0	0	0	0	0	0	1	1	0	0
Day 3	0	2	0	0	0	0	0	0	1	0	0	0
Day 4	1	2	1	0	0	0	0	0	1	0	1	1
Day 5	2	2	1	0	0	0	0	0	1	0	1	1

BODYWEIGHT

Rabbit	Sex	Initial Bodyweight (kg)	Final Bodyweight (kg)
7324	M	2.1	2.7
7325	M	2.2	2.6
7326	M	2.2	2.7
7327	M	2.4	2.8
7328	M	2.3	2.7
7329	M	2.1	2.6

Applicant's summary and conclusion

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.