D-glucitol monolaurate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Justification for type of information:

Please refer to the Analogue Approach Justification provided in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

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: Limited data given (no data on test substance purity, only 5% test substance evaluated, coexamination of substances, patients of unspecified origin, no induction application).

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Over 1200 patients with eczema were patch-tested with eight common emulsifiers, among these the test substance.

GLP compliance:

no

Type of population:

general

Subjects:

- Number of subjects exposed: 1206
- Sex: 505 men, 701 women

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: chamber method (Pirilae 1975)
- Vehicle / solvent: petrolatum
- Concentrations: 5%
- Testing/scoring schedule: occlusion time of 24 hous, and the readings were made about 20 minutes after removal of the test substance, and after 2 and 4-5 days after the application of the test substance.
- Removal of test substance: yes

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Irritant reactions were at their strongest on the first or second day, but disappeared or at least became markedly weaker within 4-5 days.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 5 (0.4%)
- Number of subjects with negative reactions: 1201
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: in 12% of the 1206 patients tested irritation of the skin was observed, no details were given for the test substance

Conclusions:

In over 1200 patients with eczema that were patch-tested with eight common emulsifiers, among these the test substance, an allergic reaction to the test substance was observed in 5 volunteers (0.4%).

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

D-glucitol monolaurate

EC Number:

247-888-8

EC Name:

D-glucitol monolaurate

Cas Number:

26657-97-6

Molecular formula:

C18H36O7

IUPAC Name:

1-O-dodecanoyl-D-glucitol

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Irritant reactions were at their strongest on the first or second day, but disappeared or at least became markedly weaker within 4-5 days.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 5 (0.4%)
- Number of subjects with negative reactions: 1201
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: in 12% of the 1206 patients tested irritation of the skin was observed, no details were given for the test substance

Source: CAS 1338-41-6, Hannuksela, 1976

Applicant's summary and conclusion

Conclusions:

In over 1200 patients with eczema that were patch-tested with eight common emulsifiers, among these the test substance, an allergic reaction to the test substance was observed in 5 volunteers (0.4%).

Executive summary:

The skin sensitisation potential of the target substance is estimated based on an adequate and reliable study of a structural analogue source substance in humans. In over 1200 patients with eczema that were patch-tested with eight common emulsifiers, among these the test substance, an allergic reaction to the test substance was observed in 5 volunteers (0.4%). Therefore, also for the target substance no skin sensitisation potential is identified. As explained in the category/analogue justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.