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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
Study period:
Phase I: 13 December 1993 to 21 January 1994; Phase II: 28 February 1994 to 9 April 1994 and Phase III: 24 May 1994 to 2 July 1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

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:
100 human subject repeat insult patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material typically contains >94% of the trans (E) isomer and 4-5% of the cis (Z) isomer.

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 110 empanelled subjects, 95 completed the test
- Sex: 31 males and 79 females
- Age: 18-62 (34 were between 18 and 30; 45 between 31 and 45 and 31 subjects aged 46-62)
- Race: No information
- Demographic information: No idiosyncratic responders to fragrance materials included; no pregnant or nursing women used. No subjects with dermatological, medical or physical conditions that precluded administration of the test material were used.
- Other: A period of at least six weeks had elapsed between this test and any other HRIPT a subject may have been empanelled on.
Clinical history:

- Other: Subjects were required to complete a medical history form prior to commencing the test but the information is not reported in the study synopsis.
Controls:
20% hexylcinnamladehyde (Sample D) was included in Panel A investigations, only applied during the challenge phase to determine possible cross sensitivity reactions.
Undiluted diethyl phthalate was included as the vehicle control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive : Using Hilltop chamber
- Description of patch: a webril/adhesive patch (25 mm Hilltop Chamber).
- Vehicle / solvent: diethyl phthalate
- Concentrations: 20% alpha amyl cinnamic aldehyde. No information provided to indicate any other concentration used
- Volume applied: 0.3 ml of test material applied per patch using Finn pipette. Patches were applied within 20 minutes of preparation or discarded
- Testing/scoring schedule: Patches were applied on nine occasions during the induction phase - Mondays, Wednesdays and Fridays for three consecutive weeks with patches removed after 24 hours and reactions assessed. After a ten day rest period following the last induction application, the challenge patch was applied to a naive site on the subject dorsum (right upper back region typically). Challenge patches were removed after 24 hours and reactions assessed immediately and again 24 and 48 hours later.
- Removal of test substance: Test sites were cleaned with distilled water prior to each patch application


EXAMINATIONS
- Grading/Scoring system: Modified six point Draize system as adopted by the International Contact Dermatitis Research Group. System described by Fischer AA in Contact Dermatitis 1986, page 26.

Results and discussion

Results of examinations:
Of the 95 subjects that completed the test, only one showed any reaction during the induction phase. A low level, maximally grade 1 - described as faint, minimal erythematous reaction - was recorded. No other reactions were observed during induction.
After the challenge application none of the test sites showed any dermal reactions

Applicant's summary and conclusion

Conclusions:
In a repeat insult patch test with 95 human subjects, the maximisation method of determiimning sensitising potential did not elicit any challenge reactions to the application of alpha-amyl cinnamic aldehyde. No evidence of contact sensitisation was found in human subjects.
Executive summary:

A panel of 110 human subjects was exposed to alpha-amyl cinnamic aldehyde in a maximised exposure protocol, repeat insult patch test. Nine occluded patches were applied in the induction phase followed by occluded challenge after a ten day rest period. Dermal reactions were assessed 24 hours after each patch application and challenge reactions also assessed at 48 and 72 hour timepoints.

95 subjects completed the test. One developed a slight reaction during the induction phase but there were no dermal reactions indicative of contact sensitisation following the challenge application.