Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
other: publication
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
other: not specified
GLP compliance:
not specified
Species:
rat
Sex:
male/female
Doses:
15 000 mg/kg bw
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
15 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 for the test substance in rats was greater than 15 000 mg/kg bw.
Executive summary:

A study was conducted to determine acute oral toxicity of the test substance. Under the study conditions, the LD50 for the test substance in rats was greater than 15 000 mg/kg bw (efsa, 2005).

Endpoint:
acute toxicity: oral
Type of information:
other: publication
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
other: not specified
GLP compliance:
not specified
Species:
rat
Strain:
other: CD
Sex:
male/female
No. of animals per sex per dose:
10 animals/sex/group
Details on study design:
14 d
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
7 000 mg/kg bw
Based on:
test mat.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the LD50 for the test substance was greater than 7000 mg/kg bw.
Executive summary:

A study was conducted to determine acute oral toxicity of the test substance. Mature CD rats (10 animals/sex/group) were fasted for 16 hours before being given the test substance at 7000 mg/kg bw. All animals were observed for clinical signs of toxicity for 14 days, after which, gross necropsies were conducted. After an initial transient 24-hour period of listlessness and diarrhoea, no further adverse effects were observed. Under the study conditions, the LD50 for the test substance was greater than 7000 mg/kg bw (efsa, 2015).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 000 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

Study 1:

A study was conducted to determine acute oral toxicity of the test substance. Mature CD rats (10 animals/sex/group) were fasted for 16 hours before being given the test substance at 7000 mg/kg bw. All animals were observed for clinical signs of toxicity for 14 days, after which, gross necropsies were conducted. After an initial transient 24-hour period of listlessness and diarrhoea, no further adverse effects were observed. Under the study conditions, the LD50 for the test substance was greater than 7000 mg/kg bw (EFSA, 2015).

Study 2:

A study was conducted to determine acute oral toxicity of the test substance. Under the study conditions, the LD50 for the test substance in rats was greater than 15000 mg/kg bw (EFSA, 2005).

Justification for classification or non-classification

The available data on the test substance indicate a low potential for acute oral toxicity. The substance does not meet the requirement for classification according to EU CLP (EC 1272/2008) criteria.