Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals and environmental conditions:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Administration / exposure

Route of administration:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Vehicle:
corn oil
Details on oral exposure:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males
5 females
Control animals:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Details on study design:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Statistics:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

Preliminary study:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Males and females: (5000 mg/kg bw) Number of animals: 5 of each sex Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: Soft stools were noted in 2 females on the day of treatment only. This was not considered as remarkable.
Body weight:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Gross pathology:
Effects on organs; no remarkable findings
Other findings:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified for acute toxicity as regards the oral route of exposure.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.

Acute toxicity was examined by using OECD Guideline 401 Annex V - Method B1

T-1540N was demonstrated not to be acutely toxic by the oral route of exposure.