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Description of key information

Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

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:
Not reported
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Reported as "Annex V"
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: Distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Doses:
no data
No. of animals per sex per dose:
5
Control animals:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Mortality:
There were no unscheduled deaths during the study.
Clinical signs:
other: Signs of sedation, exophthalmus, fuffled fur and curved body posture were noted during the study. These effects were all considered to be of slight severity and occured from 1 hour post dosing to day 10.
Gross pathology:
No treatment-related gross pathological effects were noted

None of the animals died during the study. Clinical signs observed during the study included: sedation, dyspnoea, exophthalmus, ruffled fur and curved body posture. These signs were slight in their severity and occurred from 1 hour post-dosing to day 10.

There were no effects on the organs and no treatment-related gross pathological effects were noted.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of the substance in the male and female rat was determined to be greater than 5000 mg/kg bodyweight.
Executive summary:

In an acute oral toxicity test performed using the standard acute method (method B1 of Annex V), under the conditions of GLP, the acute oral median lethal dose (LD50) of the substance in the male and female rat was determined to be greater than 5000 mg/kg bodyweight. Signs of sedation, exophthalmus, fuffled fur and curved body posture were noted during the study. These effects were all considered to be of slight severity and occured from 1 hour post dosing to day 10 but no gorss pathological efects were noted.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
Information from migrated NONS file, as per inquiry number 06-2120030080-80-0000 permission to refer granted by ECHA.

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

In an acute oral toxicity test performed using the standard acute method (method B1 of Annex V) the acute oral median lethal dose (LD50) of the substance in the male and female rat was determined to be greater than 5000 mg/kg bodyweight. Signs of sedation, exophthalmus, fuffled fur and curved body posture were noted during the study. These effects were all considered to be of slight severity and occured from 1 hour post dosing to day 10 but no gorss pathological efects were noted.


Justification for selection of acute toxicity – oral endpoint
Only available data source

Justification for classification or non-classification

The LD 50 of the substance was determined to be greater than 5000 mg/kg bodyweight and as such the substance does not require classification in accordance with Regulation (EC) no 1272/2008.