Fatty acids, lanolin, iso-Pr esters

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study which meets basic scientific principles.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Reference 2

Reference Type:

secondary source

Title:

Fianl report of the safety assessment for Isopropyl Lanolate.

Author:

CIR

Year:

1980

Bibliographic source:

Journal of environmental pathology, toxicology and oncology;4/4, 121-132, 1980

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Maximization Test (Klingmann; Journal of Investigative Dermatology; No.5; 393-409; 1966): Occlusive skin exposure on the volar forearm or the back of all volunteers for five alternate-day 48-hour periods. Site was pretreated for 24 h with 2.5 % sodium lauryl sulfate under occlusion. Following a ten day rest period a challenge patch of the test material was applied to a different site for 48 hours. Prior to challenge SLS was again applied to test site for an hour. Observations were made after removal of the challenge patch and 24 hours thereafter.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, lanolin, iso-Pr esters

EC Number:

264-119-1

EC Name:

Fatty acids, lanolin, iso-Pr esters

Cas Number:

63393-93-1

Molecular formula:

UVCB

IUPAC Name:

Fatty acids, lanolin, isopropyl esters

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Composition of test material, percentage of components: Two percent isopropyl lanolate in a soft, non-pourable cream with a low pH in a non-ionic oil-in-water emulsion

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 25
- Sex: 4 males, 21 females
- Age: 19 - 43
- Race: 3 black females, rest is given as white

Controls:

none

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Testing/scoring schedule: five alternate day, 48-hour periods with patch on the volar forearm or the back; patch site pretreated with 2.5% SLS (24 hours), after ten days rest different site was pretreated with 5-10 % SLS for an hour and then patch test with test substance was applied for 48 hours; scores were determined immediately after removal of patch and 24 hours thereafter
- Other: a pre-test was done to determine use of SLS; 48 hour occlusive patch test on volar forearm or the back with test substance

EXAMINATIONS
- Grading/Scoring system: see Table1 under Any other information on materials and methods including tables

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: no symptoms observed at both reading time points

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 25

Applicant's summary and conclusion

Conclusions:

not sensitizing to human skin at 2%