Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Piperonylbutoxide
IUPAC Name:
Piperonylbutoxide
Details on test material:
Piperonyl butoxide (PBO)

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight recorded weekly
Statistics:
Not required

Results and discussion

Preliminary study:
No
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
All animals gained the expected body weight.
Gross pathology:
No pathological changes were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
LD50 (oral, rat) exceeded 2000 mg/kg bw.
Executive summary:

In an acute oral toxicity study according to GLP and TG OECD 423 a group of 6 female rats received a single dose of 2000 mg/kg bw neat Piperonylbutoxide by gavage. There were no mortalities and no clinical signs. Body weights were not affected and no pathological changes were observed.

LD50 (rat, oral) exceeded 2000 mg/kg bw.