Reaction Mass of (E,E)-2,6-dimethylocta-2,4,6-triene and (E,Z)-2,6-dimethylocta-2,4,6-triene

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation, other

Remarks:

Maximisation test in humans

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

other: RIFM Database

Title:

Unnamed

Year:

1982

Report date:

1982

Reference 2

Reference Type:

other: Monograph

Title:

2,6-Dimethyl-2,4,6-Octatriene

Year:

1988

Bibliographic source:

Food and Chemical Toxicology 26 (4), 309

Materials and methods

Principles of method if other than guideline:

- Principle of test: Maximisation test in humans
- Short description of test conditions: Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour period. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a ten to fourteen day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. A fifth site challenged with petrolatum served as control. Test item concentration was based on a reported maximum concentration of 0.1% in consumer products.

GLP compliance:

no

Type of study:

patch test

Test material

Test material information

1

Reference substance name:

(E,E)-2,6-dimethylocta-2,4,6-triene

EC Number:

221-153-1

EC Name:

(E,E)-2,6-dimethylocta-2,4,6-triene

Cas Number:

3016-19-1

Molecular formula:

C10H16

IUPAC Name:

(E,E)-2,6-dimethylocta-2,4,6-triene

Test material form:

liquid

Specific details on test material used for the study:

The test material (E,E)-2,6-dimethylocta-2,4,6-triene (EC 221-153-1) is the constituent of the registered substance.

In vivo test system

Test animals

Species:

other: human

Sex:

male/female

Details on test animals and environmental conditions:

22 male and female human volunteers

Results and discussion

Positive control results:

No

In vivo (non-LLNA)

Results

Key result

Reading:

other:

Group:

test chemical

Dose level:

1%

No. with + reactions:

0

Total no. in group:

22

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Conclusions:

Skin sensitisation not observed in healthy male and female human volunteers in the maximisation test performed with 2,6-dimethyl-2,4,6 -octatriene (CAS 3016-19-1). Test item concentration was based on a reported maximum concentration of 0.1%
in consumer products.

Executive summary:

Skin sensitisation not observed in healthy male and female human volunteers in the maximisation test performed with 2,6-dimethyl-2,4,6 -octatriene (CAS 3016-19-1). Test item concentration was based on a reported maximum concentration of 0.1% in consumer products.