Methoxycarbonyloxycyclooct-4-ene

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

The study was conducted between 10 June 1985 and 19 July 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reliability 2 is assigned because the method is according to standard HRIPT guidelines and the results are reliable but without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

No guideline available. The study was performed according to the Abbreviated Shelanski and Shelanski Repeated Insult Patch Test Procedure (Ref. P.I. Protocol No. PT/I9/C1).

GLP compliance:

no

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 53 (4 males and 49 females).
Human adult volunteers were included in the study, unless they had a systemic illness which might have contra-indicated participation, or a skin disease with manifestations which might be misconstrued as an irritant effect of the test material, or they were taking medications which might augment or suppress the irritant effects of the test material.

Human volunteers represented a randomly selected group of panellists from the local population.

Age of the volunteers was between 35-76 years (males) and 26-70 years (females).

Clinical history:

A history of past and present health status and medication intake was obtained from each of the individuals. A brief physical examination was performed in orde to detect and eliminate any who evidenced any finding which could be a basis for exclusion (systemic illness, skin diseases, intake of medications).

Controls:

No

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Human Repeated Insult Patch Test

ADMINISTRATION
- Type of application: semi-occlusive
- Description of patch: webril pad of a Readi-Bandage
- Vehicle / solvent: Diluent 85-209
- Concentrations: 2% v/v solution
- Volume applied: 0.2 mL
- Testing/scoring schedule:
* Induction phase: Patches were applied to the same site (back) for three consecutive weeks on Monday, Wednesday and Thursday for a total of 9 applications. Patches were removed on Friday. Scoring was done on Tuesday, Wednesday, Thursday and Friday (24 hours after application of the patches) after which a freshly prepared patch was applied to the same site (except for Friday).
Challenge phase: following a 2-week rest period, the challenge patches were applied to previously untreated test site. After 24 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48, 72 and 96 hours.

EXAMINATIONS
- Grading/Scoring system: see 'Any other information on materials and methods incl. tables'
- Statistical analysis: none performed

Results and discussion

Results of examinations:

No. of subjects showing positive/irritating reactions to the substance in the induction phase: 0
The absence of visible responses during the induction phase indicated that the substance, tested at 2% v/v in Diluent 85-209 was incapable of acting as a primary irritant of either the immediate or cumulative type in any of the individuals.

No. of subjects showing positive/irritating reactions to the substance in the challenge phase: 0
The absence of visible responses as a result of the challenge application indicated that the substance, tested at 2% v/v in Diluent 85-209, was incapable of acting as a primary irritant of the immediate type in any of the individuals on the sites utilized for the challenge application.

There was no evidence that the substance has sensitising properties.

Any other information on results incl. tables

From the data, it can be deduced that one volunteer was absent during the entire study after the first application.

Number of volunteers that missed one induction: 6

Number of volunteers that missed two induction: 4

Number of volunteers that missed five inductions: 2

Applicant's summary and conclusion

Conclusions:

In a Human Repeated Insult Patch Test, application of 0.2 mL with 2% substance was not sensitising under the conditions of the test in 53 subjects.

Executive summary:

A Human Repeated Insult Patch Test was performed according to the Abbreviated Shelanski and Shelanski Repeated Insult Patch Test Procedure (Ref. P.I. Protocol No. PT/I9/C1). The substance was evaluated for skin sensitising properties in an induction phase, followed by a rest period of 2 weeks and a challenge phase.

The induction phase took place on Monday, Wednesday and Thursday in which 9 applications in total were made in 3 weeks. The amount of volume applied was 0.2 ml, test concentration used was 2% in Diluent 85 -209. During the induction patches were placed at the back of the volunteers. Patches were replaced by freshly prepared patches 24 hourrs after application, on Wednesday and Thursday. Scoring for reactions was done 24 hours after each application. On Friday patches were removed. Two weeks after the final induction treatment, a challenge patch was applied to untreated sites of the back and removed after 24 hours. Reactions to the challenge were assessed after 24, 48, 72 and 96 hours. None of the 53 subjects tested was sensitised by the sample. It was therefore concluded that the test substance is not sensitising at the concentration tested.