Registration Dossier

Administrative data

Endpoint:
skin sensitisation, other
Remarks:
The sample was sent to Centre for Toxicology and Development Research (CEFT), Sri Ramachandra medical Centre, Chennai-600116, India
Type of information:
experimental study
Adequacy of study:
key study
Study period:
44 Days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Results and discussion

In vivo (LLNA)

Results
Key result
Parameter:
other: Not specified in the study report
Remarks on result:
other: As per OECD 406, its Weak Sensitizer, Grade 1

Applicant's summary and conclusion

Interpretation of results:
other: As per OECD 406, it is a weak sensitizer,Grade 1
Conclusions:
2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane is a ''Weak Sensitizer, Grade 1" as classified according to OECD harmonised classification System during the test period.
The method followed for the classiication is " Magnusson and Kligman" rating of Allergenicity.
The complete study was performed in compliance with OECD guidelines number 406.