Oxacycloheptadec-10-en-2-one

Endpoint summary

Description of key information

Skin Sensitization:

A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization study was conducted to evaluate the toxic nature of the test compound.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ambrettolide
- Molecular formula : C16H28O2
- Molecular weight : 252.395 gram/mol
- Substance type: Organic
- Physical state: Liquid

Species:

other: human

Strain:

other: not applicable

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Patients with suspected contact dermatitis from 9 university hospitals in Korea
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From April 2002 to June 2003

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5%

Day(s)/duration:

no data available

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

5%

Day(s)/duration:

No data available

Adequacy of challenge:

not specified

No. of animals per dose:

422 Korean patients

Details on study design:

Finn Chambers on Scanpor fape (Epitest, Tuusula, Finland) tape was used for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.
- No. of exposures: No data available
- Exposure period: No data available
- Test groups: 422
- Control group: No data available
- Site: Most common site was the Face. Neck, trunk, eyelid, lips, hand, arm, leg, scalp, ear, foot and widespread areas were also evaluated.
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: 5%

Challenge controls:

No data available

Positive control substance(s):

not specified

Reading:

1st reading

Group:

test chemical

Dose level:

5%

No. with + reactions:

0

Total no. in group:

422

Clinical observations:

Negative result were observed in 422 patients.

Remarks on result:

no indication of skin sensitisation

Interpretation of results:

other: not sensitising

Conclusions:

No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.

Executive summary:

A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies have been summarized to determine the allergenic potential of the test chemical in living organisms.The studies are based on in vivo experiments in guinea pigs as well as humans for the various test chemicals.

Study 1:

A patch test was conducted for test chemical on 422 patients suspected with contact allergy who visited the hospitals over the period April 2002 to June 2003 in 9 university hospitals in Korea. Each patient was exposed to 5% of test chemical in petrolatum by using Finn Chambers on Scanpor tape (Epitest, Tuusula, Finland) for patch testing, and the results were evaluated according to the recommendation of the International Contact Dermatitis Research Group.No dermal reactions were observed in the 422 patients suspected with contact allergy. Thus, based on these observations and results, the test chemical was considered to be not sensitizing to skin.

Study 2:

This is supported by the results of a Repeated Insult Patch Test (RIPT) conducted to determine if test chemical would induce dermal sensitization in human volunteers. During the induction phase 0.5 ml of 0.5% (382µg/cm2) of chemical in ethanol was applied onto the upper arm of 38 human volunteers for 24 hours in a 1 x 1 semi-occlusive patch. The applications were made to the same site on Monday, Wednesday and Friday for a total of nine applications during 3-week period. Following a 10-day rest period, a challenge patch was applied to a site previously un-exposed. Patches were applied as in the induction phase and kept in place for 24 h after which time they were removed. Reactions to the challenge were scored at 24 and 72 hours after application. None of the volunteers developed skin sensitization reactions at 24 and 72 hrs after challenge exposure. The test material was considered to be not sensitizing on human volunteers.

Study 3:

These results are supported by an Open epicutaneous test conducted on Guinea Pigs to evaluate the skin sensitization potential of the test chemical. During the test, 6-8 guinea pigs were induced with the test chemical at concentration of 100, 30, 10, 3, 1% which was followed by challenge exposure of 1% applied dermally.

Since none of the treated animals showed skin reactions at challenge concentration, the test chemical was considered to be not sensitizing on guinea pigs’ skin.

Study 4:

The above results are further supported by the Human maximization test carried out in 26 volunteers to assess the skin sensitizing behavior of test chemical. About 1% of the test chemical in petrolatum was applied on each volunteer. None of the volunteers showed any cutaneous reaction, hence, the test chemical considered to be not sensitizing to the human skin.

Study 5:

These results are lent support by another Repeated Insult Patch Test (RIPT) conducted to determine the skin sensitization potential of test chemical in 58 volunteers. Each subject were exposed to 2% of the test chemical in DMP under occlusive condition and then observed for 48-72 hours for skin reactions. Negative skin reactions were observed after 72 hours. Hence the test chemical was considered to be not sensitizing to the human skin.

Study 6:

These results are also supported by the human maximization test was conducted on 25 volunteers for test chemical to determine the skin irritancy potential caused by the chemical. During the test, 30% of test chemical in petrolatum was applied on skin of each volunteer followed by observation of skin reactions.

It was noted that none of the 25 volunteers had developed any skin lesions or allergic reaction. Hence the test chemical was not sensitizing to the human skin.

Available studies for test chemical indicate that it lacks the potential to cause any dermal reaction to the skin. Hence, it can be considered to be not sensitizing to skin.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Available studies for the test chemical indicate that it is not likely to cause any dermal sensitization. Hence, the test chemical can be considered to be not sensitizing to skin as per the CLP classification.