Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, 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:
104 days
Reliability:
1 (reliable without restriction)
Justification for type of information:
Acute Dermal Irritation/ Corrosion study is done in Newzealand White rabbit as per OECD 404. It is an in-vivo Study.

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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
animal:
Time point:
other: 1hr, 24hr, 48hr, 72hr, 7days and 14days
Score:
>= 0 - <= 1.67
Max. score:
1.67
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
other: Non irritant as per Harmonised Integrated Classification System
Conclusions:
2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane did not cause any irritation in any of the NewZealand White rabbits during the test period.
So, 2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane is classified as "Non-irritant" as per Harmonised Integrated Classification System .
The complete study was performed in compliance with OECD guidelines number 404.