Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

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Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
80% Polyethylene glycol 400 (PEG 400) in distilled water
Doses:
300, 2000 mg/kg
No. of animals per sex per dose:
3
Control animals:
yes
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no unscheduled deaths.
Clinical signs:
There were no test item-related clinical findings during the study.
Body weight:
There were no test item-related changes on body weight during the study.
Other findings:
Macroscopic findings: There were no test item-related gross changes.
Interpretation of results:
GHS criteria not met
Conclusions:
The test item resulted in no test item-related changes or findings after single oral administration by 2000 mg/kg in female SD rats in this study.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

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Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
other: Acute Dermal Toxicity Study
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Vehicle:
propylene glycol
Remarks:
80% Polyethylene glycol 400 (PEG 400) in distilled water
Duration of exposure:
15 days
Doses:
0, 500, 1000, 2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes
Key result
Sex:
male/female
Dose descriptor:
LD50 cut-off
Effect level:
> 2 000 mg/kg bw
Mortality:
Test-item related mortality was not observed in all male and female groups
Interpretation of results:
GHS criteria not met

Additional information

Justification for classification or non-classification