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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

oral LD50 > 2000 mg/kg bw = no hazard identified
dermal LD50 > 2000 mg/kg bw = No hazard identified
inhalation LC50: waived = hazard unknown (no further information required)

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 2007-12-18
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: HsdRccHan : WIST rats (Full-Barrier)
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
The test item was administered in a single dose by gavage using an intubation cannula.
Control animals:
no
Statistics:
not necessary
Sex:
male/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:
other: Signs of toxicity related to dose levels: No treatment related effect was observed during the course of the study.
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 substance shows no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the substance 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 Klimisch Score 1 study

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 2007-12-12
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:
HsdRccHan : WIST rats (Full-Barrier)
Type of coverage:
semiocclusive
Vehicle:
corn oil
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:
other: Signs of toxicity related to dose levels: No treatment related effects observed.
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 substance 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 Klimisch Score 1 study

Additional information

During the whole life cycle of the substance and especially during its use in technical plastic articles, the oral, dermal or inhalation exposure of workers can be excluded, and there is no relevant exposure to consumers, as the substance is embedded into a polymer matrix. The information that would be obtained from an additional acute inhalation study is considered not to be needed, as oral, dermal, and respiratory exposure is avoided by safety measures which are already in place in case of potential dusty work places, and consumer exposure can be excluded. In view of animal welfare and to avoid unnecessary animal testing it was decided to waive such a study.


Justification for selection of acute toxicity – oral endpoint
one sufficient study

Justification for selection of acute toxicity – dermal endpoint
one sufficient study

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.