Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - June 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
UVCB substance
Specific details on test material used for the study:
Batch no.: PE00138468
Expiry date : 20 February 2018

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Age : 6-7 weeks old
Weight range at arrival : 168.3-189.3 grams

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
300 mg/kg
2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality and no clinical signs were observed in animals of the first group initially dosed at 300mg/kg (Group 12, Step 1). No mortality occurred and no clinical signs were seen in the further group of 3 females dosed at the same dose level (Group 21, Step 2) and in the two groups of 3 females each dosed at 2000mg/kg (Group 24, Step 3; Group 27, Step 4).
Clinical signs:
No mortality and no clinical signs were observed in animals of the first group initially dosed at 300mg/kg (Group 12, Step 1). No mortality occurred and no clinical signs were seen in the further group of 3 females dosed at the same dose level (Group 21, Step 2) and in the two groups of 3 females each dosed at 2000mg/kg (Group 24, Step 3; Group 27, Step 4).
Body weight:
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
Gross pathology:
No abnormalities were observed at necropsy examination performed on all animals dosed at 300 and 2000mg/kg (Groups 12, 21, 24 and 27) at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

The acute toxicity of JASMONYL LG was investigated following a single oral administration at the doses of 300 and 2000mg/kg (10mL/kg in 0.5% aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period.

No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000mg/kg.

These results indicate that the test item JASMONYL LG did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000mg/kg. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000mg/kg body weight.