Registration Dossier

Administrative data

Description of key information

LD50(oral) > 2,000 mg/kg

LD50(dermal) > 2,000 mg/kg

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
Study period:
2007
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)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
6 female
Control animals:
yes
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study, similar between
treated and control animals.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related
changes.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50(oral) > 2,000 mg/kg
Executive summary:

No mortality occured during the study.

No clinical signs related to the administration of the test item were observed.

The body weight evolution of the animals at the end of the study between treated and control animals were similar.

The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
sufficient

Acute toxicity: via inhalation route

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
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
occlusive
Vehicle:
water
Doses:
2000 mg/kg bw/day
No. of animals per sex per dose:
5
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
no
Body weight:
no significant deviations
Gross pathology:
no macroscopic changes of the organs
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
not classified as "acute toxic"
Executive summary:

The test item did not reveal acute toxic effects after dermal exposure against rats.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
sufficient

Additional information

Justification for selection of acute toxicity – oral endpoint
Study with the highest reliability amongst all studies on the subject "acute tox oral"

Justification for selection of acute toxicity – dermal endpoint
Only available study

Justification for classification or non-classification

Test results do not suggest classification into one of the categories of the hazard class "acute toxicity".