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Administrative data

Description of key information

LD50, oral > 2000 mg/kg bw
LD50, dermal > 2000 mg/kg bw
acute Tox. inhalation: waived

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:
from 2007-11-20 till 2007-12-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species/strain: Wistar Hsd:HanRcc (SPF)
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Aqua ad inject
Control animals:
no
Statistics:
not necessary
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No treatment related effect was observed during the course of the study.
Body weight:
Throughout the 14-days observation period weight loss was recorded for animal 2 in step 1, loosing weight between the first and the second week. No weight loss was recorded in any other animal. The weight gain was within the expected range.
Gross pathology:
Effects on organs:
No treatment related effects were observed in any animal of any steps.
Other findings:
none
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item shows no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test item was classified into Category 5 (LD50 cut-off: unclassified).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
GLP compliant study with Klimisch score 1

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:
from 2007-11-26 till 2007-12-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
92/69/EWG, B.3
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species/strain:
rat, Wistar Hsd:HanRcc (SPF)
Type of coverage:
semiocclusive
Vehicle:
other: aqua ad inject
Duration of exposure:
24 h
No. of animals per sex per dose:
5 males/ 5 females
Control animals:
no
Statistics:
not necessary
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
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 treatment related effects observed.
Body weight:
see Table 1
Gross pathology:
Effects on organs:
No treatment related effects observed.
Other findings:
Signs of toxicity (local):
No treatment related effects observed.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item has no acute dermal toxic characteristics. The dermal LD50 was determined to be > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
GLP compliant study with Klimisch score 1

Additional information

In both studies, oral and dermal, no clinical signs of toxicity were observed throughout the observation period. Except for acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in any animals. Weight gain of all animals was within the expected range.


Justification for selection of acute toxicity – oral endpoint
The only existing study is sufficient

Justification for selection of acute toxicity – inhalation endpoint
Inhalation is not expected to be a relevant exposure path for the substance. The substance as a salt has a very low vapour pressure and after manufacturing and processing it remains embedded into polymer matrix.

Justification for selection of acute toxicity – dermal endpoint
The only existing study is sufficient

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding acute toxicity to mammals.