Lanolin, hydroxylated

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Remarks:

Skin irritation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

28 February 1977 to 8 April 1977

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

Study type:

study with volunteers

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

53 human volunteers were used to test the irritation potential of the test material under conditions of a stringently supervised and monitored patch test. The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%.

GLP compliance:

no

Remarks:

Not applicable

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

Method

Type of population:

general

Subjects:

- Number of subjects exposed:
- Age: 18 or over
- Known diseases: Absence of skin disease. General well-being.

Ethical approval:

confirmed, but no further information available

Route of exposure:

dermal

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

20%, 40%, 60%, 80%, and 100% concentration with a density of application of approximately 0.1 rnL/cm²

Group I - 11 Subjects - 60% in petrolatum.
Group II - 11 Subjects - 20% in petrolatum.
Group III - 11 Subjects - 100% as supplied.
Group IV - 11 Subjects - 80% in petrolatum.
Group V - 11 Subjects - 40% in petrolatum.
(2 subjects dropped out prior to the initiation of the study in groups III and V, leaving a total of 53 subjects during the remainder of the study).

Examinations:

Evalutated after 24 hours to determine skin irritation.

Reactions were evaluated according to the following scale:

0 = No visible erythema
1 = Erythema
2 = Erythema plus swilling
3 = Erythema, swelling, plus papules
4= Severe irritation consisting of erythema, swelling, papules and necrosis and extension beyond the areas of contact.

Results and discussion

Results of examinations:

The test material at concentrations ranging from 20 % to 100 %, did not elicit any visible evidence of irritatyion in any of the individuals under the test.

Applicant's summary and conclusion

Conclusions:

The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%, which produced no visible damage to the skin of any of the 53 individuals who completed the test. The test material was concluded to be incapable of acting as a primary skin irritant under the conditions of the test.

Executive summary:

53 human volunteers were used to test the irritation potential of the test material under conditions of a stringently supervised and monitored patch test. The test material was tested in concentrations of 20%, 40%, 60%, 80%, and 100%, which produced no visible damage to the skin of any of the 53 individuals who completed the test. These observations would indicate that the use of this substance, even in the higher concentrations, should pose no significant hazard.

The test material was concluded to be incapable of acting as a primary skin irritant under the conditions of the test.