Soaps, stocks, vegetable-oil, acidulated

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From October 23, 1995 to December 1, 1995

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:

1996

Report date:

1996

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A human repeat insult patch test was carried out on 88 volunteers. The substance was tested at a concentration of 50% v/v in liquid paraffin which was also included in the study as a control material. 24 h induction patches were applied 3 d/wk for 3 wks followed by challenge patch application after 14 d of rest. The test sites were scored before application of subsequent patches during the induction phase and 48 and 96 h after challenge application.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 and C18-unsatd.

IUPAC Name:

Glycerides, C16-18 and C18-unsatd.

Constituent 2

Reference substance name:

Glycerides, C16-18 and C18-unsatd.

EC Number:

266-948-4

EC Name:

Glycerides, C16-18 and C18-unsatd.

IUPAC Name:

266-948-4

Constituent 3

Reference substance name:

67701-30-8

Cas Number:

67701-30-8

IUPAC Name:

67701-30-8

Details on test material:

- Name of test material: Cremeol PS-17; which contains:
Partially hydrogenated soybean oil: 50% (CAS N° 8016-70-4, EC N° 232-410-2); under the SDA nomenclature, the name of this substance is ‘Glycerides, C16-18 and C18-unsatd.’
Partially hydrogenated palm oil: 50%
- Physical state: Light amber liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 88
- Sex: Male/Female
- Age: > 18 yrs

Clinical history:

No data

Controls:

Concurrent vehicle (Liquid Paraffin) applied to volunteers

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Application site: Arm
- Description of patch: 2 cm X 2 cm square Werbil pads located down the center line of a piece of Blenderm tape. A patch with 3 Werbil squares comprised one patch strip.
- Vehicle/solvent: Liquid paraffin
- Concentrations: 50% v/v
- Volume applied: 0.3 mL
- Testing/scoring schedule: 24 h induction patches applied 3 d/wk for 3 wks followed by challenge patch application after 14 d of rest. The test sites were scored before application of subsequent patches during the induction phase and 48 and 96 h after challenge application.


EXAMINATIONS
- Grading/Scoring system:
0 No visible erythema
1 Mild erythema (faint pink to definite pink)
2 Moderate erythema (definte response)
3 Severe erythema (very intense redness)

Oedema, papules, vesicles and bullae, if present, are graded as independent responses.

Results and discussion

Results of examinations:

Induction: No skin irritation reactions during induction phase
Challenge: No evidence of skin sensitization at challenge

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Based on the results, the substance was found to be non-sensitizing in human repeat insult patch test at concentration of 25%.

Executive summary:

A human repeat insult patch test was carried out on 88 volunteers with ‘glycerides, C16-18 and C18-unsatd.’ (as Cremeol PS-17 containing partially hydrogenated soybean oil: 50%; partially hydrogenated palm oil: 50%). Cremeol PS-17 was tested at a concentration of 50% v/v in liquid paraffin (i.e. the concentration of partially hydrogenated soybean oil was 25%) which was also included in the study as a control material. 24 h induction patches were applied 3 d/wk for 3 wks followed by challenge patch application after 14 d of rest. The test sites were scored before application of subsequent patches during the induction phase and 48 and 96 h after challenge application. The substance neither produced irritation during the induction nor elicited reactions indicative of sensitization at challenge. Based on the results, the substance was found to be non-sensitizing in human repeat insult patch test at concentration of 25% (Cuthbert and Neilson, 1996).