Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 03, 2017 to October 18, 2017
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 to 18 October 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The acute oral toxicity study was undertaken as a bridging study to demonstrate equivalence between the Target substance (XP 475) and the Source substance (XP 338; CAS 569318-35-0) for the read-across of other data. A full discussion of read-across and supporting data is given in the attached justification.
Reason / purpose:
read-across source
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Reason / purpose:
read-across: supporting information
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
17th December 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Female, nulliparous and non pregnant animals.
Age of animals: Young adult rat, 8-9 weeks old in sighting and in main study.
Body weight in sighting study: 191 g.
Body weight range in main study: 193 - 214 g.
Route of administration:
oral: gavage
Vehicle:
other:
Remarks:
The test item was dosed as a formulation in Helianthi annui oleum raffinatum solution.
Details on oral exposure:
A single oral administration - followed by a fourteen-day observation period - was performed by gavage.
Doses:
Starting dose of the sighting study was selected on the OECD Guideline No.:420. A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
No. of animals per sex per dose:
Starting dose of the sighting study was selected on the OECD Guideline No.:420. A sighting study starting dose of 2000 mg/kg followed by dosing of a further four animals at this level as a limit test for relevant guideline.
Control animals:
yes
Details on study design:
Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out 14th day after the treatment.
Preliminary study:
No lethality was noted at after a single oral dose of 2000 mg/kg bw.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The rat (No.: 7548) dosed at 2000 mg/kg bw XP 475 did not die in sighting study.
No deaths occurred at the 2000 mg/kg single oral dose of the test item in the main study. All rats survived until the end of the 14-day observation period.
Clinical signs:
No treatment related symptoms were observed in the 2000 mg/kg bw dose group throughout the 14-day post-treatment period.
Body weight:
The mean body weight of animals treated with 2000 mg/kg bw dose corresponded to their species and age throughout the study.
Gross pathology:
All animals treated with 2000 mg/kg bw of the test item survived until the scheduled necropsy on Day 14.
Slight hydrometra was observed in female No.: 7548 and severe hydrometra was detected in animal No.: 7551, respectively. Hydrometra is physiological finding and connected to the oestrus cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of animals treated with 2000 mg/kg bw of the test item.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 >2000 mg/kg.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Visual inspection of test substance.
GLP compliance:
yes

Test material

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

Results and discussion

Physical state at 20°C and 1013 hPa:
liquid
Form / colour / odour
Key result
Form:
liquid
Colour:
Amber viscous liquid.
Odour:
other: Characteristic odor

Applicant's summary and conclusion

Conclusions:
Amber viscous liquid. Characteristic odor.