Registration Dossier
Registration Dossier
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EC number: 200-076-7 | CAS number: 51-03-6
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Piperonyl butoxide
- IUPAC Name:
- Piperonyl butoxide
- Details on test material:
- Piperonyl butoxide (PBO)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT, Löhndorf , Germany
- Age at study initiation: 5-7 months
- Weight at study initiation: 2.1-2.4 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: 07.06. - 13.06.2007
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL undiluted PBO
- Duration of treatment / exposure:
- 24 hours after administration the eyes were rinsed with 20 mL aqueous NaCl
solution. - Observation period (in vivo):
- up to 5 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24-7 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24-72h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.44
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.78
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
Any other information on results incl. tables
| Cornea (opacity) | Iris | Conjunctivae (redness) | Chemosis (lids and/or nictating membrane) | |
| Animal No | 1/2/3 | 1/2/3 | 1/2/3 | 1/2/3 |
| before dosing | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 |
| 60 min | 0/0/0 | 0/0/0 | 1/1/1 | 0/0/0 |
| 24 h | 0/2/2 | 0/1/1 | 1/1/1 | 0/1/1 |
| 48 h | 0/2/2 | 0/1/1 | 0/1/1 | 0/0/1 |
| 72 h | 0/1/1 | 0/0/0 | 0/1/1 | 0/0/0 |
| 4 days | -/0/0 | -/0/0 | -/1/1 | -/0/0 |
| 5 days | -/0/0 | -/0/0 | -/0/0 | -/0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No classification and labelling required
- Executive summary:
In a primary eye irritation study according to TG OECD 405 and GLP 0.1 mL PBO were instilled into one eye of each of three Himalayan rabbits. Treated eyes were washed after 24 h.
There were no systemic reactions.
Corneal opacity was observed in two animals at 24 and 48 h (grade 2) and 72 h (grade 1) after instillation.
Irritation of the iris (grade 1) was observed in two animals at 24 and 48 h after instillation.
Conjunctival redness (gade 1) was observed in all animals at 1 and 24 h, in two animals until 48 h after instillation.
Chemosis (grade 1) was observed in two animals at 24 h and in one anima at 48 h after instillation.
No classification and labelling with reagrd to eye irritation is required.
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