Soybean oil, deodorizer distillate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not applicable

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is well documented, meets generally accepted scientific principles

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

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 study was conducted to evaluate the allergenic potential of ingestion of soybean oil in soybean-sensitive individuals. Seven soybean sensitive patients were enrolled in a double-blind cross-over study. On four separate days, patients were challenged with the individual soybean oils and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the soybean oils or olive oil contained in 1 mL capsules.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, C16-18 and C18-unsatd.

EC Number:

266-948-4

EC Name:

Glycerides, C16-18 and C18-unsatd.

Cas Number:

67701-30-8

IUPAC Name:

Glycerides, C16-18 and C18-unsatd.

Constituent 2

Reference substance name:

6701-30-8

IUPAC Name:

6701-30-8

Details on test material:

- Name of test material (as cited in study report): Partially hydrogenated (CAS N° 8016-70-4, EC N° 232-410-2), unhydrogenated (CAS N° 8001-22-7, EC N° 232-274-4) and cold-pressed soybean oils; under the SDA nomenclature, the name of these substances is ‘Glycerides, C16-18 and C18-unsatd.’
- Storage condition of test material: Individual oils were placed in separate gelatin capsules (1 ml per capsule), were packaged in coded plastic bags so that neither of the patient nor the physician would know which material was being administrated, and were frozen.

Method

Type of population:

not specified

Ethical approval:

not specified

Subjects:

7 patients (3 males and 4 females) and with a history of an immediate hypersensitivity reaction after ingestion of soybeans were recruited from the allergy clinics at the University of Wisconsin, Madison.

Clinical history:

Clinical summary of patients

No Age Sex Atopic history* Age Last exposure Reaction after Other legume sensitivity***
on set (in years) ingestion**
1 32 M - 8 3 RD, U GB, L, P, PN
2 63 F - 56 2 AE, LE, W -
3 18 F A, AR, E Infancy 6 AP, LE, U, W LB, P. PN
4 21 M A 8 3 AE, U, W GB, P, PN
5 50 M HS 30 <1 AE, U.W KB, L
6 38 F A, AR Infancy 10 R, U, W LB, KB, PN
7 21 F A, AR 20 <1 RD, W PN

*Atopic disease: A = asthma: AR = allergic rhinitis; E = eczema; HS = Hymenoptera sensitivity.
**Reaction: AE = angioedema; AP = abdominal pain; LE = laryngeal edema: R = rhinitis; RD = respiratory distress: U = urticaria:
W = wheezing.
***Legumes: GB = garbanzo bean; KB = kidney bean: L = lentil; LB = lima bean; P = pea; PN = peanut nut.

Controls:

Olive oil

Route of administration:

oral

Details on study design:

Seven soybean sensitive patients were enrolled in a double-blind cross-over study. All patients had elevated levels of serum IgE antibodies to the crude soybean extract; binding values ranged from 2.3 to 28.1 times that of a negative control serum. Before the oral challenges, all the patients demonstratednegative puncture skin tests to three commercially available soybean oils and olive oil (control). On four separate days, patients were challenged with the individual soybean oils and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the soybean oils or olive oil contained in 1 mL capsules.

Results and discussion

Results of examinations:

No untoward reactions were observed with either the commercially available soybean oils or olive oil.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

The test substance ingestion does not appear to pose any risk of allergenicity in soybean-sensitive individuals.

Executive summary:

A study was conducted to evaluate the allergenic potential of ingestion of ‘glycerides, C16-18 and C18-unsatd.’ (as soybean oil) in soybean-sensitive individuals.

Seven soybean sensitive patients were enrolled in a double-blind cross-over study. All patients had elevated levels of serum IgE antibodies to the crude soybean extract. Before the oral challenges, all the patients demonstrated negative puncture skin tests to three commercially available the test substance and olive oil (control). On four separate days, patients were challenged with the individual test substances and olive oil in random sequence. At 30 min intervals, under constant observation, patients ingested 2, 5 and 8 mL of one of the test substance or olive oil contained in 1 mL capsules.

No untoward reactions were observed with either the test substance or olive oil.

The test substance ingestion does not appear to pose any risk of allergenicity in soybean-sensitive individuals.