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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Guideline:
other: Appraisal of the safety of chemicals in foods, drugs and cosmetics (FDA)
Principles of method if other than guideline:
Guidelines were not available when study was conducted. Basically according to OECD401.
GLP compliance:
no
Remarks:
GLP was not implemented at the time of the study
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
0.71; 1.00; 1.41; 2.00 g/kg bw
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
980 mg/kg bw
Based on:
test mat.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Based on this study conducted by an appraisal of the safety of chemicals in foods, drugs and cosmetics (Food and Drug Association) the LD50, oral, rat was determined to be 980 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
980 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

With an LD50 (oral, rat) of 980 mg/kg the substance must be classified for acute toxicity category 4 with H302 (harmful if swallowed)

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