Lanolin, hydrogenated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key 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:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

The primary dermal irritation of the substance in rabbits was evaluated by the test method described in Draize et al.1944

Draize, J.H., Woodard, G. and Calvery, H.O. 1944. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J.Pharm. & Ex. Ther. 82, 377.

GLP compliance:

no

Remarks:

study was performed before GLP

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

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.8-2.4 kg.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped and abraded

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml (0.5 g).

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

six

Details on study design:

TEST SITE
- Area of exposure: the trunk of animal. The test material was applied to clipped areas of intact and abraded skin.
- Type of wrap if used: applications were made under occlusive patches (1'' x 1'' gauze, covered by adhesive tape). An impermeable occlusive wrapping was used.
Other: the abrasions were longitudinal epidermal incisions sufficiently depp to generate the stratum corneum but not so deep as to destroy the integrity of the derma.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hrs folowing application.

OBSERVATION TIME POINTS: at 24 and 72 hours the test sites were observed for erythema and edema.

SCORING SYSTEM:
- Method of calculation: the sites were individually examined and scored separately for edema and erythema at 24 and 72 hours.
Erythema and Edema formation
very slight erythema (barely perceptible) 1
well defined erythema 2
moderate to severe erythema 3
severe erythema (beet redness) to slight eschar formation
(injuries in depth) 4
total possible erythema score = 4
Edema formation
very slight edema (barely perceptible) 1
slight edema (edges of area well defined by definite raising) 2
moderate edema (area raised appr. 1 mm) 3
severe edema (raised more than 1 mm and extending beyond
area of exposure) 4
total possible edema score = 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3, #4, #5

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Remarks on result:

other: clipped and abraded

Results 2

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 hrs

Remarks on result:

other: clipped and abraded

Results 3

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: clipped and abraded

Any other information on results incl. tables

The summary of scores for skin irritation is presented in the table below.

Table

Rabbit no	Skin	24 hours		72 hours
		Erythema	Edema	Erythema	Edema
1	NA	1	0	0	0
	A	1	0	0	0
2	NA	1	0	0	0
	A	1	0	0	0
3	NA	1	0	0	0
	A	1	0	0	0
4	NA	1	0	0	0
	A	1	0	0	0
5	NA	1	0	0	0
	A	1	0	0	0
6	NA	1	0	1	0
	A	1	0	1	0

NA = Non-abraded skin

A = Abraded skin

Applicant's summary and conclusion

Interpretation of results:

other: not classified as skin irritant according to CLP Regulation (EC) No.1272/2008

Conclusions:

Non-skin irritant

Executive summary:

The substance was evaluated for its skin irritation potential according to a test method described by Draize et al. (1944). The substance was applied in the trunk of 6 New Zealand albino rabbits, to clipped areas of intact and abraded skin. Following application the trunk of each animal was covered with an impermeable occlusive wrapping. 24 hours following application the wrapping and test substance were removed and the test sited were individually examined and scored for erythema and edema at 24 and 72 hours.

The mean score for erythema (24 /72 hours) was 0.66 for 5 rabbits (reversible within 48 hrs) and 1 for all rabbits whereas edema was 0 for all animals.

Taking in consideration the erythema and edema score, it can be considered that the substance is not a skin irritant to rabbits.