Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to guideline in effect at time of study conduct.
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect dated 2002.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
-Purity: 97.6%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3260-3348 g
- Housing: Singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): 125 g rabbit chow daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Approximately 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2°C
- Humidity (%): 50±10%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each rabbit was not treated and served as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
1, 24, 48, 72 hours following administration
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes remained unwashed.

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: Illumination, magnification, and biomicroscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: range
Time point:
other: 1 hour to 72 hours
Score:
0
Max. score:
0
Irritation parameter:
other: biomicroscope
Basis:
other: range
Time point:
other: 24 hours to 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test substance produced conjunctival redness in 1 rabbit.

Any other information on results incl. tables

Table 1: Individual Animal Ocular Effects

 

Rabbit No.

Cornea

Iritis

Conjunctiva

Biomic

Opacity

Area

Redness

Chemosis

Discharge

1 Hour

27898

0

0

0

0

0

0

-

27861

0

0

0

1

0

0

-

27848

0

0

0

0

0

0

-

24 Hours

27898

0

0

0

0

0

0

0

27861

0

0

0

1

0

0

0

27848

0

0

0

0

0

0

0

48 Hours

27898

0

0

0

0

0

0

0

27861

0

0

0

0

0

0

0

27848

0

0

0

0

0

0

0

72 Hours

27898

0

0

0

0

0

0

0

27861

0

0

0

0

0

0

0

27848

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: other: EEC Directive 91/325
Conclusions:
The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability). The overall conjunctival chemosis, conjunctival redness, iritis, and corneal opacity scores were 0, 0.11, 0, and 0, respectively.
Executive summary:

The test substance was evaluated for acute eye irritation potential in 3 young adult New Zealand white rabbits. An aliquot of approximately 0.1 mL of the test substance was administered to 1 eye of each animal. The eyes remained unwashed following treatment. The untreated eye served as a control. The conjunctiva, iris, and cornea of each treated eye were evaluated and scored according to a numerical scale approximately 1, 24, 48, and 72 hours following administration. Under the conditions of the study, the test substance produced conjunctival redness in 1 rabbit. Mean values were calculated from the quantitative evaluation of ocular lesions observed in all rabbits at 24, 48, and 72 hours following administration. The overall conjunctival chemosis, conjunctival redness, iritis, and corneal opacity scores were 0, 0.11, 0, and 0, respectively.