2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether

Acute Toxicity: dermal

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

Test material information

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.