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Administrative data

Description of key information

Although the intraperitoneal injection studies in the rat returned results of LD50 male 944 mg/kg bw and female 874 mg/kg bw, which implies a classification of Acute Toxicity 4, they will not be used for classifcation as this is not an accepted route for human exposure.

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:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Doses:
0(vehicle), 1000, 1500, 2000 mg/kg bw
No. of animals per sex per dose:
Five males and five females were assigned to each dose.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study.
Clinical signs:
One female was observed with temporary loose stool at 2000 mg/kg bw. No clinical signs were observed in the animals given 1000 and 1500 mg/kg bw.
Body weight:
In male rats, body weight gain significantly decreased (p<0.05) at 1500 mg/kg bw on Days 1-2 and Days 1-4. At 2000 mg/kg bw, however, no significant difference in body weight gain was noticed at any point in time.
In female rats, suppression of body weight gain was observed at a dose of 1500 mg/kg bw and higher on Days 1-4. On Days 4-8, however, their body weight gain was significantly higher (p<0.05) than that in the control.
Gross pathology:
No macroscopic abnormalities were observed at autopsy for any doses in either sex.
Interpretation of results:
GHS criteria not met
Conclusions:
The result of acute oral toxicity LD50 >2000 mg/kg bw results in a not classified verdict.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Klimisch 1

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

Although the intraperitoneal injection studies in the rat returned results of LD50 male 944 mg/kg bw and female 874 mg/kg bw, which implies a classification of Acute Toxicity 4, they will not be used for classifcation as this is not an accepted route for human exposure.

This substance is not classified for acute toxicity.