Registration Dossier

Administrative data

Description of key information

Acute Toxicity Oral: LD50 >5000 mg/kg bw (male/female rat, standard acute method). 

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:
Details not available
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: Crl : COBS CD (SD) BR
Sex:
male/female
Details on test animals and environmental conditions:
Details not available
Route of administration:
oral: unspecified
Vehicle:
other: 1% Aqueous methylcellulose
Details on oral exposure:
Details not available
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males & 5 females
Control animals:
not specified
Details on study design:
Details not available
Statistics:
Not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
not specified
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:There were no deaths. Signs of reaction to treatment observed in all rats within three hours of dosing were piloerection, increased salivation, abnormal body carriage (hunched posture), abnormal gait (waddling) and diarrhoea. Complete recovery was reached 2 days after treatment.
Body weight:
Slightly low bodyweight gains were recorded on Day 8 for two male rats.
Gross pathology:
Terminal autopsy findings were normal. Effects on organs: None seen.
Other findings:
Not specified
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
LD50 >5000 mg/kg bw
Executive summary:

The acute toxicity: oral was measured using the OECD 401 and EU B1 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. LD50 >5000 mg/kg bw.    

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw
Quality of whole database:
K1

Additional information

Justification for selection of acute toxicity – oral endpoint
Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.

Justification for classification or non-classification

The substance is not classified under CLP as it does not fill the requirements for classification.