Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

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

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: 8-10 weeks
- Weight at study initiation: 205 - 246 g
- Fasting period before study: overnight
- Housing: singly
- 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): no data
- Photoperiod (hrs dark / hrs light): 12h each

IN-LIFE DATES: From:2007-05-30 To: 2007-07-05

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 6 cm
- % coverage:10%
- Type of wrap if used: gauze and plastic sheet

REMOVAL OF TEST SUBSTANCE
- At the end of the exposure period no residual item had to be removed

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.87 mL = 2000 mg/kg bw
- Concentration (if solution): neat
- Constant volume or concentration used: yes/
- For solids, paste formed: not applicable
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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: daily
- 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:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
None
Body weight:
Not affected
Gross pathology:
No changes
Other findings:
No skin reaction

Applicant's summary and conclusion

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

In an acute dermal toxicity study according to GLP and TG OECD 402 a group of 5 female and 5 male rats received a single dose of 2000 mg/kg bw of neat Piperonylbutoxide by the dermal route. There were no mortalities and no clinical signs. Bodyweights were not affected and no pathological changes were observed.

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