Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

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

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: LPT, Löhndorf , Germany
- Age at study initiation: 5-7 months
- Weight at study initiation: 2.2-2.5 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30% - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: From: 05.06. - 09.06.2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- % coverage:
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No residual test item had to be removed as no test item was left on the skin after
removal of the patch.

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Skin irritation scores (erythema)

   Animal 1  Animal 2  Animal 3
 Before dosing  0 0  0
 60 min  1  1  1
 24 h  1  1  1
 48 h  1  0  0
 72 h  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating
Executive summary:

In a primary skin irritation study according to GLP and TG OECD 404 0.5 mL of the test substance were applied to the shaved skin of three male rabbits for 4 h with semi-occlusive dressing.

No oedema and were noted. Erythema were very slight (score 1) at 1 and 24 h after patch removal for all animals and for one animal at 48 h. At 72 h there were no more skin reactions.

PBO is not irritating to the skin.