Registration Dossier
Registration Dossier
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EC number: 200-076-7 | CAS number: 51-03-6
Skin irritation / corrosion
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:
- 2 007
- 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
- Reference substance name:
- Piperonylbutoxide
- IUPAC Name:
- Piperonylbutoxide
- Details on test material:
- Piperony butoxide (PBO)
Constituent 1
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.
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