Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 129
Version / remarks:
The study design was based on the OECD Guidance document on using cytotoxicity tests to estimate
starting doses for acute oral systemic toxicity tests. No. 129, 20th July 2010.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Specific details on test material used for the study:
CAS number in the study report (18871-14-2) indicates the main component in Jasmonyl. However recent analytical data shows that Jasmonyl is a reaction mass of nonane-1,3-diyl diacetate and tetrahydro-3-pentyl-2H-pyran-4-yl acetate. The test substance used in this study was Reaction mass of nonane-1,3-diyl diacetate and tetrahydro-3-pentyl-2H-pyran-4-yl acetate.

Test animals

Species:
other: Mouse fibroblast cell line, Balb/c 3T3, clone A31, from the American Type Culture Collection (ATCC cell line No. CCL-163).

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 586 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the experimental conditions of this study, the test item, Jasmonyl, is not considered as cytotoxic in this in vitro test system up to the highest tested concentration of 100 μg/mL. Taking into account this highest tested concentration, the test item LD50 is estimated to be greater than 586 mg/kg.