Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material: CP12
- Lot/batch No.: 0012
- Storage condition of test material: Room temperature in the dark.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Age at study initiation: 15 - 17 weeks
- Weight at study initiation: 2.9 kg
- Housing: conventional, singly housed in metal cages with perforated noryl floors
- Diet (e.g. ad libitum): Stanrab (P) from Special Diet Services UK, ad libitum
- Water (e.g. ad libitum): Municipal supply ad libitum
- Acclimation period: at least 10 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 2012-10-15 To: 2012-11-05

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1, 24, 48 and 72 hours, 7, 14 and 21 days after application
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize scale, according to test guideline

TOOL USED TO ASSESS SCORE: None

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1.7
Max. score:
4
Irritant / corrosive response data:
Response was assessed in a single animal. Well defined conjunctival chemosis and moderate redness were observed 1, 24 and 48 hours post-exposure. Seventy-two hours after exposure, slight chemosis and severe redness were observed. Slight redness was still observed after 7 and 14 days. Slight discharge and chemosis were noted after 14 days after dosing. Slight corneal opacity with the area of cornea involved greater than half was observed from 1 hour post-exposure up to the end of the observation period (21 days after treatment). The extension of the opacity gradually decreased from 48 hour post-exposure.

AVERAGE SCORE
- Cornea: 1.0
- Iris: 0.0
- Conjuntivae (Redness): 2.3
- Conjuntivae (Chemosis): 1.7

Any other information on results incl. tables

Irritant/corrosive response data at each observation time

 


Score at time point / Reversibility

Cornea

Iris

Conjunctival redness

Conjunctival chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 minutes

1

0

2

2

24 hours

 1

 0

2

 2

48 hours

 1

 0

 2

 2

72 hours

 1

 0

 3

 1

7 days

 1

 0

 1

 0

14 days

 1

 0

 1

 1

21 days

 1

 0

 0

 0

 

Average 24, 48, 72 hours

 

1.0

 

0.0

 

2.3

 

1.7

 

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Acute eye irritation has been investigated in the rabbit in accordance with OECD test guideline No. 405. Significant irritation was observed that had not resolved within 21 days.
Executive summary:

Acute eye irritation has been investigated in the rabbit in accordance with OECD/EU test guideline No. 405. Significant irritation was observed that had not resolved within 21 days.