Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
Acute Toxicity test is performed at sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, 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:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Karanaorg was found to be "unclassified" or "catagory 5" as per GHS.
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
corn oil

Results and discussion

Preliminary study:
Under the conditions of acute oral toxicity study in female rats: the acute oral LD50 of KARANAORG was found to be greater than 2000 mg/kg body weight and is classified as "catagory 5" or "Unclassified" as per GHS.
Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Classified as Catagory 5 as per GHS

Applicant's summary and conclusion

Conclusions:
The Acute Oral Toxicity for 2-(2,4-Dimethylcyclohex-3-ene-1-yl)-5-methyl-(1-methylpropyl)-1,3-dioxane is performed as per OECD 423 guideline on Wistar rats . LD 50 for the compound was found to be >2000mg/Kg body weight and is classified as Category 5 / Unclassified as per GHS .