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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only secondary literature and original report not available

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Final report of the amended safety assessment of Glyceryl Laurate, Glyceryl Laurate SE, Glyceryl Laurate/Oleate, Glyceryl Adipate, Glyceryl Alginate, Glyceryl Arachidate, Glyceryl Arachidonate, Glyceryl Behenate, Glyceryl Caprate, Glyceryl Caprylate, Glyc
Author:
Cosmetic Ingredient Review (CIR)
Year:
2004
Bibliographic source:
Int J Toxicol. 2004;23 Suppl 2:55-94
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Modified Draize repeat insult patch test in healthy volunteers (single-blind)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-dihydroxypropyl laurate
EC Number:
205-526-6
EC Name:
2,3-dihydroxypropyl laurate
Cas Number:
142-18-7
Molecular formula:
C15H30O4
IUPAC Name:
2,3-dihydroxypropyl laurate
Details on test material:
- Name of test material (as cited in study report): Glyceryl laurate
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 91
- Sex: male and female
- Age: 18 to 65 years
Controls:
Liquid paraffin was simulateously applied as negative control.
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: 5 cm wide stripe of Scanpor tape to which Finn chambers were fixed in pairs.
- Vehicle / solvent: liquid paraffin
- Concentrations: 50% (w/v)
- Amount applied: 0.02 g previously heated to 60 °C
- Testing/scoring schedule:

Group 1 (39 subjects):
Induction patches: Days 1 (23 h), 2, 4, 7, 9, 11, 14, 16 and 18 (47 h each). Reactions were scored after each patch removal.
Challenge patch: Day 35 (47 h). Reactions were scored 1 and 49 h after patch removal.

Group 2 (52 subjects):
Induction patches: Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 (47 h each). Reactions were scored after each patch removal.
Challenge patch: Day 35 (47 h). Reactions were scored 1 and 49 h after patch removal.

EXAMINATIONS
- Grading/Scoring system: Reactions were scored according to a scale ranging from 0 (no visible reaction) to 5 (bullous reaction).
- Evaluation: Classification of the test material as irritating was based on 10% of the induction scores defined as > 1 (mild erythema). Sensitisation was defined as a rapid response to the challenge application, being characterised by severe erythema and edema (usually with papules/vesicles).

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: The test material induced mild erythema during the induction phase in most of the subjects and questionable reactions during the challenge phase in seven subjects. During induction and challenge (1 and 49 h post-removal) phases, reactions ranged from 1 (mild erythema) to 2 (moderate erythema).

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/74
- Number of subjects with negative reactions: 67/74
- Number of subjects with equivocal reactions: 7/74
- Number of subjects with irritating reactions: most of the subjects during the induction phase (number not specified)

Any other information on results incl. tables

From the 91 subjects at the beginning of the study, 17 withdrew for reasons either unrelated to treatment (16 subjects) or because the patch was painful (1 subject).

Applicant's summary and conclusion

Conclusions:
Not sensitising