Registration Dossier

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

Referenceopen allclose all

Reference Type:
other: RIFM Database
Title:
Unnamed
Year:
1982
Report Date:
1982
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

Reference
Name:
Unnamed
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 group
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.