Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from peer-reviewed hadbook or collection of data. Reliable source (GESTIS)

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2009

Materials and methods

Principles of method if other than guideline:
According to Annex VII "Standard Information Requirements for Substances Manufactured or Imported in Quantities of one Tonne or More" of the "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC” (as amended) (OJ L 396, 30.12.2006, p 1), 8.5, a study on acute toxicity is required under certain conditions. However, as the substance is classified and the acute toxicity an be assessed, (animal) testing is not required
GLP compliance:
not specified
Test type:
other: Assessment and expert judgement
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Quelle : 02071
Toxicological Data, compiled by the National Institute of Health (NIH), USA, selected and distributed by Technical Database Services (TDS), New York, 2009
no other information available in the GESTIS: http://biade.itrust.de/biade/lpext.dll/Infobase/uberschrift43397?f=templates&fn=main-h.htm&2.0

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not reported
Doses:
no information available
No. of animals per sex per dose:
no information available
Control animals:
not specified
Details on study design:
no information available
Statistics:
no information available

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
100 mg/kg bw
Based on:
test mat.
Remarks on result:
other: limited data base

Any other information on results incl. tables

Acute oral data retrieved from GESTIS (Gefahrstoff-Informations-System der Berufsgenossenschaften http://gestis.itrust.de)

Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfallversicherung (IFA)
Division 1
Alte Heerstr. 111
53757 Sankt Augustin
Germany

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 oral rat 100 mg/kg