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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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
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.