Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to TG OECD 403

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 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Piperonybutoxide
IUPAC Name:
Piperonybutoxide

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Charles River Laboratories, Germany
- Age at study initiation: 50-64 days
- Weight at study initiation: 208-240 g
- Fasting period before study: 16 h
- Housing:
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C±3°C
- Humidity (%): 55%±15%
- Air changes (per hr): 10 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours each

IN-LIFE DATES: From: 2007-05-30 To: 2007-10-30

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose only
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: according to Kimmerly&Tepper
- Source and rate of air: 22.5 changes per hour
- Method of conditioning air: no data
- System of generating aerosols: spray jet
- Method of particle size determination: Cascade impactor
- Treatment of exhaust air: no data
- Temperaturein air chamber: 22°C ± 3°C)

TEST ATMOSPHERE
- Brief description of analytical method used: gravimetrically
- Samples taken from breathing zone: yes


TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 29.1% of the particles were <4 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.624 /4.03
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetry, once every hour
Duration of exposure:
4 h
Concentrations:
5.2±0.2 mg/L air
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.2 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: revealed slightly reduced motility, slight ataxia and slight dyspnoea. No mortality did occur
Mortality:
No mortality
Clinical signs:
other: Slightly reduced motility, slight ataxia and slight dyspnoea.
Body weight:
All animals gained the expected body weight throughout the study period
Gross pathology:
No pathological findings were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
LC50 exceeded 5.2 mg/L the limit dose tested
Executive summary:

In an acute inhalation toxicity study according to GLP and TG OECD 403 a group of 5 male and 5 female rats was exposed to an aerosol of 5.2 mg Piperonylbutoxide/L air for 4h. There were no mortalities and clinical signs were confined to slightly reduced motility, slight ataxia and slight dyspnoea. Bodyweights were not affected and no pathological changes were observed.

LC50 exceeded 5.2 ± 0.2 mg/L air.