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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
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
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:
other: There were no test item-related clinical findings 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

Link to relevant study records
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

Link to relevant study records
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
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