Lanolin, hydrogenated

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

January 1972 to June 1973

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:

1975

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Patch testing with anhydrous lanolin and two preparations of hydrogenated lanolin were applied to the intact skin of 756 patients with contact dermatitis. Every individual showing a positive response more than ++ to any of the material was subjected to two series of further patch tests.

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin, hydrogenated

EC Number:

232-452-1

EC Name:

Lanolin, hydrogenated

Cas Number:

8031-44-5

Molecular formula:

UVCB: not available

IUPAC Name:

Lanolin, wool wax, hydrogenated

Method

Type of population:

other: patients

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 756

Clinical history:

- History of allergy or casuistics for study subject or populations: the subjects were attending the clinic because of contact dermatitis.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION: the subjects were patch tested with anhydrous lanolin (JP) and two preparations of hydrogenated lanolin (lanocerina extra and Lanol A) that were applied in standard fashion to the grossly intact skin. Every individual who showed a positive response more than ++ to any of the materials was subjected to two series of further patch tests.
Year 1972: patch tests with anhydrous lanolin and hydrogenated lanolin to 502 dermatologic patients.
Year 1973 (January-June): patch tests with the same but ageing anhydrous lanolin and hydrogenated lanolin to 254 additional patients.
January 1972-June 1973: patch tests with betamethasone-17-valerate ointment and the lanocerina extra were carried out in 87 patients with suspected dermatitis from the applied ointment.
Patch tests with a seried of anhydrous lanolin and hydrogenated lanolin preparations supplied by the Takasago Perfumery Co were performed in 24 of the 52 subjects sensitive to anhydrous lanolin JP and/or either or both hydrogenated samples (lanocerina extra and/or lanol A) in January 1972-June 1973 and in the additional 24 subjects from July 1973 to June 1974.

PREPARATION OF TEST MATERIALS:
A. Series of anhydrous lanolin preparations in various stages of modification, supplied by the Takasago Perfumery Co Ltd.
1. Lanolin FC: acid value 1.0-3.0, inferior to lanolin in the JP grade.
2. Lanolin FP: licensed by the Japanese Pharmacopoeia; acid value less than 1.0
3. Lanolin Super: made from lanolin FP by oxidative bleaching
4. Lanolin SP: made from lanolin FP by distillation
5. Lanolin SPM: made from lanolin SP by fractionation with organic solvents.
6. Residue No.19: recovered from the solvents after lanolin SPM is extracted from lanolin SP.
B. Series of hydrogenated lanolin preparations: anhydrous lanolin of the JP grade is completely hydrogenated under a high pressure (200 atm) in the presence of nickel as a catalyst.
1. Lanol A: completely hydrogenated product of lanolin FP
2. Lanol S: made from Lanol A by vapor distillation
3. Lanol 3S: made from Lanol S by molecular distillation
4. Fraction No. 103: initial fraction in the process of molecular distillation of lanol S
5. Lanocerina extra: used in the base of betamethasone-17-valerate ointment and supplied by the Shionogi Pharmaceutical Co.

Results and discussion

Results of examinations:

- During patch tests with anhydrous lanolin and hydrogenated lanolin to 502 dermatologic patients (year 1972): 10 (1.99 % incidence) patients showed positive test reactions more than ++ (erythema with oedema) to patch tests with anhydrous lanolin (JP), while 26 (5.18 %) reacted with hydrogenated lanolin (lanocerina extra).
- During patch tests with the same but ageing anhydrous lanolin and hydrogenated lanolin to 254 additional patients (Year 1973 (January-June)): 11 (4.33 %) and 12 (4.72 %) patients were positive to anhydrous lanolin and hydrogenated lanolin respectively.
- During patch tests with betamethasone-17-valerate ointment and the lanocerina extra were carried out in 87 patients with suspected dermatitis from the applied ointment (January 1972-June 1973): 28 showed positive reactions to the ointment and 29 to hydrogenated lanolin. 26 patients showed a positive response to both materials.
- Patch tests with a series of anhydrous lanolin and hydrogenated lanolin preparations supplied by the Takasago Perfumery Co were performed in 24 of the 52 subjects sensitive to anhydrous lanolin JP and/or either or both hydrogenated samples (lanocerina extra and/or lanol A) in January 1972-June 1973 and in the additional 24 subjects from July 1973 to June 1974: the proportion of positive responses more than (++) to each preparation decreased with each stage of purification.

Any other information on results incl. tables

The results of skin reactions to a series of anhydrous lanolin and hydrogenated lanolin are presented in the table below.

Table

Series of anhydrous lanolin preparations
Period	Lanolin FC	Lanolin FP	Lanolin Super	Lanolin SP	Lanolin SPM	Residue 19
Jan 1972-Jun 1973	16/24 (66.7 %)	13/24 (54.2 %)	5/24 (20.8 %)	3/24 (12.5 %)	0/5 (0.0 %)	2/5 (40.0 %)
Jul 1973-Jun 1974	14/24 (58.3 %)	8/24 (33.3 %)	1/3 (33.3 %)	3/24 (12.5 %	2/24 (8.3 %)	12/24 (50.0 %)
Total	30/48 (62.5 %)	21/48 (43.8 %)	6/27 (22.2 %)	6/48 (12.5 %)	2/29 (6.9 %)	14/29 (48.3 %)
Series of hydrogenated lanolin preparations
Period	Lanocerina extra	Lanol A	Lanol S	Lanol 3S	Fraction 103
Jan 1972-Jun 1973	18/24 (75.0 %)	13/24 (54.2 %)	0/5 (0.0 %)	0/5 (0.0 %)	3/5 (60.0 %)
Jul 1973-Jun 1974	22/24 (91.7 %)	15/24 (62.5 %)	5/24 (20.8 %)	5/24 (20.8 %	17/24 (70.8 %)
Total	40/48 (83.3 %)	28/48 (58.3 %)	5.29 (17.2 %)	5/29 (17.2 %)	20/29 (69.0 %)

Applicant's summary and conclusion

Conclusions:

The results in 1972 showed that the incidence of sensitivity to hydrogenated lanolin was significantly higher than that to anhydrous lanolin at the 1 % level, while no significant difference was found between both samples in 1973.

Executive summary:

756 subjects were patch tested with anhydrous lanolin and two preparations of hydrogenated lanolin that were applied to the intact skin of patients with contact dermatitis. Every individual showing a positive response more than ++ to any of the material was subjected to two series of further patch tests.

The results of skin reactions to a series of anhydrous and hydrogenated lanolin preparations in the screened patients revealed that the incidence of skin sensitivity decreased with every stage of purification. The results in 1972 showed that the incidence of sensitivity to hydrogenated lanolin was significantly higher than that to anhydrous lanolin at the 1 % level, while no significant difference was found between both samples in 1973. Contamination by traces of copper, chromium and nickel in hydrogenated preparations is considered, by the study, to be the source of other possible allergens.