Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-09-01 to 2014-09-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
October 2, 2012
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
May 30, 2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
August 1998
Deviations:
no
Qualifier:
according to
Guideline:
other: Japan MAFF Testing Guideline of 12 Nousan No. 8147; November 24, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bioassay-Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany

Test material

Reference
Name:
Unnamed
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands and Charles River Wiga GmbH, Germany
- Age at study initiation: Approx. 3 - 5 months
- Weight at study initiation: 2.53 kg – 4.36 kg
- Housing: individually
- Diet: ad libitum (STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany)
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: adjacent eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: treated eyes were rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 hours

SCORING SYSTEM: The evaluation of eye irritation was performed according to the quoted guidelines.
Cornea opacity:
Degree of density (the most dense area is taken for reading)
0 No ulceration or opacity
1 Slight: Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 Moderate: easily discernible translucent area, details of iris slightly obscured
3 Marked: nacreous area, no details of iris visible, size of pupil barely discernible
4 Severe: opaque cornea, iris not discernible through the opacity

Iris:
0 Normal
1 Moderate: markedly deepened congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 Severe: no reaction to light, haemorrhage, gross destruction (any or all of these)

Conjunctivae redness: (Refers to palpebral and bulbar conjunctivae, not to cornea and iris)
0 Blood vessels normal
1 Slight: some blood vessels definitely hyperemic (injected)
2 Obvious: diffuse, crimson color, individual vessels not easily discernible
3 Severe: diffuse beefy red

Chemosis:
Lids and/or nictitating membrane
0 No swelling
1 Slight: any swelling above normal (includes nictitating membranes)
2 Moderate: obvious swelling with partial eversion of lids
3 Marked: swelling with lids about half closed
4 Severe: swelling with lids more than half closed

TOOL USED TO ASSESS SCORE: Hand slit lamp, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Slight conjunctival redness (grade 1) was noted in all animals from 1 hour up to 24 hours after application and persisted in one of these animals until hour 72. Slight conjunctival chemosis (grade 1) was noted in all animals 1 hour after application and persisted in one animal until hour 24. Slight discharge (grade 1) was noted in two animals 1 hour after application, while in the third animal obvious discharge (grade 2) was observed at the same reading time point. In all animals circular injected scleral vessels were noticed at hour 1. In two of these animals injected scleral vessels in a circumscribed area were noted from hour 24 until hour 48. The ocular reactions were reversible in two animals within 48 hours and in one animal within 7 days after application.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met