Fatty acids, tallow, calcium salts

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: GLP-status not known, guideline not known, information from a peer-reviewed, published review article. Notable limitations in design and/or reporting, reliability not known.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1982

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Type of sensitisation studied:

skin

Study type:

not specified

Principles of method if other than guideline:

- Method: Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects. A 24-hour challenge patch was then applied after two weeks rest and observations made at 24, 48 and 72 hours.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium stearate

EC Number:

212-490-5

EC Name:

Sodium stearate

Cas Number:

822-16-2

IUPAC Name:

sodium stearate

Test material form:

other: Stick deodorant formulation

Details on test material:

No data reported

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

No data reported

Clinical history:

No data reported

Controls:

No data reported

Route of administration:

dermal

Details on study design:

- Method: Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects. A 24-hour challenge patch was then applied after two weeks rest and observations made at 24, 48 and 72 hours.

Results and discussion

Results of examinations:

- Induction results: 59 slight, one moderate and one severe erythema reactions occurred during the two week induction period.
- Challenge results: Seven light erythema reactions were seen at 24 hours after the challenge patch application, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative.

Applicant's summary and conclusion

Conclusions:

Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects causing 59 slight, one moderate and one severe erythema reactions. A 24-hour challenge patch was then applied after two weeks rest and seven light erythema reactions were seen at 24 hours, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative.

Executive summary:

Undiluted stick deodorant formulation containing 7 % sodium stearate was applied four days a week for two weeks as eight 12-hour patches to the medial surface of the upper arm of 212 subjects causing 59 slight, one moderate and one severe erythema reactions. A 24-hour challenge patch was then applied after two weeks rest and seven light erythema reactions were seen at 24 hours, with one slight erythema reaction at the 48 hour observation and by 72 hours, all eight sites were negative. No information on the test methods used is available in the publication (CIR 1982). However, this information is taken from a peer reviewed article and can be considered adequate for use for this endpoint.