Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
please see report attached

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
please see report attached
Doses:
please see report attached
No. of animals per sex per dose:
please see report attached
Control animals:
yes
Details on study design:
please see report attached
Statistics:
please see report attached

Results and discussion

Preliminary study:
please see report attached
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Based on:
test mat.
Mortality:
please see report attached
Clinical signs:
please see report attached
Body weight:
please see report attached
Gross pathology:
please see report attached
Other findings:
please see report attached

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information if swallowed Criteria used for interpretation of results: EU
Conclusions:
According to the classification criteria laid down in Council Directive 67/548/EEC (and
subsequent adaptations) on the approximation of the laws, regulations and administrative
provisions relating to the classification, packaging and labeling of dangerous substances,
concerning the potential toxicity by oral route, the test item Acide trifluoro 3.4.5 phenylboronique
should be assigned the symbol Xn, the indication of danger "Harmful" and the risk phrase R 22:
"Harmful if swallowed".