Registration Dossier
Registration Dossier
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EC number: 202-928-3 | CAS number: 101-25-7
Endpoint summary
Administrative data
Description of key information
REACH_LD50 = 940 mg/kg bw | rat | - | #WoE#
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1967
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 6w oral and i.p. administration including preliminary experiments on acute i.p. toxic effects; acute poisening test (Bordas and Sziza)
- GLP compliance:
- no
- Test type:
- other: not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- other: oral: unspecified and i.p.
- Vehicle:
- other: aqueous suspension stabilized with acacia gum
- Details on oral exposure:
- no further details
- Doses:
- Acute oral: 940 mg/kg
Acute i.p.: 640, 420, 280, 200 mg/kg
Subacute i.p.: 180, 150, 120, 80 mg/kg/d - No. of animals per sex per dose:
- Acute oral/i.p.: not specified in detail (i.p. 1-6)
Subacute: 6 EEG group, 10 conditioned reflex group - Control animals:
- other: vehicle control group in the subacute experiment
- Details on study design:
- Acute toxicity was tested in preliminary experiments (oral and i.p., not specified in detail).
In the main experiment, the subacute i.p. toxicity regarding nervous effects was tested in rats including an EEG group and a conditioned reflex group. - Statistics:
- Not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 940 mg/kg bw
- Based on:
- test mat.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Remarks:
- subacute (6 w)
- Effect level:
- 253 mg/kg bw
- Based on:
- test mat.
- Sex:
- not specified
- Dose descriptor:
- LD100
- Remarks:
- subacute (6w)
- Effect level:
- 470 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Not specified in detail
- Clinical signs:
- other: Preliminary test (acute i.p.): spasmodic attacks; acute oral no details Subacute experiment: At beginning free of symptoms then sudden onset of spasms
- Gross pathology:
- No data for acute administration
- Other findings:
- Subacute experiment: Changes in the nervous system at higher doses i.p.
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity was tested in preliminary experiments resulting in a LD50 of 940 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No details reported
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Specific details on test material used for the study:
- not specified
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Doses:
- 2.9 g/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 900 mg/kg bw
- Mortality:
- LD50 exceeded 2.9 g/kg bw in rats; no further details
- Clinical signs:
- other: Poisening was accompanied by convulsions, tremor, respiratory system damage
- Gross pathology:
- not specified
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 exceeded 2.9 g/kg bw in rats.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 940 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
Acute oral Toxicity
The LD50in an acute oral toxicity study was determined to be 940 mg/kg. Other authors reported an LD50> 2900 mg/kg in rats. Effects seen were convulsions, tremor and respiratory tract damage. Available information indicate that classification for acute oral toxicity category 4 is warranted.
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