Registration Dossier

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:
2007
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

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

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.