Registration Dossier

Administrative data

Description of key information

LD50 > 2000 mg/kg b.w. The substance is not toxic for oral exposure
LD50 > 2000 mg/kg b.w. The substance is not toxic for dermal exposure

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)
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:CD(SD)BR
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No clinical signs occurred in the treated animals. Body weight growth of the treated animals was normal during the observationperiod.
Gross pathology:
Effects on organs:
At the final killing no appreciable macroscopic findings were evident in any treated rat.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test conducted according to internationally accepted testing guidelines.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Test conducted according to internationally accepted testing guidelines.

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)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
not specified
GLP compliance:
yes
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Crl:CD(SD)BR
Type of coverage:
semiocclusive
Duration of exposure:
24 h
Control animals:
yes, concurrent no treatment
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No clinical abnormalities were seen in any treated animal.
Gross pathology:
Effects on organs:
No appreciable changes were evident in the treated animals of either sex at the autopsy carried out at the end of the observationperiod.
Other findings:
Signs of toxicity (local):
No clinical abnormalities were seen in any treated animal.
Interpretation of results:
other: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Test conducted according to internationally accepted testing guidelines.

Additional information

All tests of acute toxicity shows a values above the trigger value of 2000 mg/kg b.w, therefore no classification is warranted.

Justification for classification or non-classification

No classification for acute toxicity oral is warranted under Regulation 1272/2008

No classification for acute toxicity inhalation is warranted under Regulation 1272/2008

No classification for acute toxicity dermal is warranted under Regulation 1272/2008