Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 August, 2017 to 27 November, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
(cyclohex-3-en-1-yl)methyl 2-hydroxypropanoate
EC Number:
946-283-2
Cas Number:
1864727-96-7
Molecular formula:
C10H16O3
IUPAC Name:
(cyclohex-3-en-1-yl)methyl 2-hydroxypropanoate

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)
Sex:
female
Details on test animals or test system and environmental conditions:
9 week-old at dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
three
Control animals:
no
Details on study design:
The dose level was set at 300 mg/kg for experiment 1 and 2 and 2000 mg/kg for experiment 3 and 4. Three females were used in each experiment. Clinical observation and body weight measurement were conducted after administration and necropsy was performed after the completion of a 14-day observation period.
Statistics:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
other: Decrease in locomotor activity was transiently noted after dosing in experiment 3 and 4.
Gross pathology:
No macroscopic change was noted in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the test substance has a LD50 above 2000 mg/kg bw and therefore is not classified according to the GHS criterias.