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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
suspension of the substance in 0.5% aqueous sodiumcarboxymethyl cellulose
Doses:
2100 mg/kg bw
No. of animals per sex per dose:
Male: 2100 mg/kg bw; Number of animals: 5
Female: 2100 mg/kg bw; Number of animals: 5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 100 mg/kg bw
Based on:
not specified
Mortality:
Male: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2100 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: There were no deaths and no signs of toxicity
Gross pathology:
Effects on organs: No effects were observed at necropsy.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 100 mg/kg bw
Quality of whole database:
Three studies available, GLP compliant, done according to EU-methods annex V, B1

Additional information

Acute oral toxicity: three studies are available, all of them following the EU Method B1. The results are respectively >2100 mg/kg bw, >2000 mg/kg bw and >5000 mg/kg bw showing a profile non toxic for this substance.


Justification for selection of acute toxicity – oral endpoint
see discussion

Justification for classification or non-classification

LD50 (oral)=2100 mg/kg bw. The value is above the limit 2000 mg/kg bw for classification. Therefore the substance is not classified for acute oral toxicity hazard.