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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Justification for type of information:
Justification for read across is detailed in the report attached to the IUCLID section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Real Decree 363/1995 and Real Decree 1078/93
Principles of method if other than guideline:
Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation
GLP compliance:
no
Remarks:
Centre Certificated ISO 9001 by National Accreditation Programme (certificate N. 98 - 1101)

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: certificated provider
- Sex: males
- Housing: individual inoxidable steel cages, Tecniplast
- Diet: daily 150 g of special fodder for experimental rabbits, supplied by an authorized provider
- Water: automatic ad libitum, treated and filtered
- Marking: tatoo on the upper side of ear
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 25
- Air changes (per hr): 15 changes of pre-filtered air per hour
- Photoperiod (hrs dark / hrs light): 12/12

Other materials used:
Balance: COBOS D 6000-SX
Gloves: vinyl and latex gloves
Syringes: 1 mL of volume
Manual lamp
Wash bottle with saline solution
Colircusi fluorescein or equivalent authorized

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: in case of liquid substance were administrated 0.1 mL, in case of solid substance 0.1 g
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
TOOL USED TO ASSESS SCORE: light of a manual lamp for examing the reactions and fluorescein for evaluating corneal lesions

SCORING SYSTEM:
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity: 0 Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
details of iris clearly visible: 1
Easily discernible translucent area; details of iris slightly obscured: 2
Nacrous area; no details of iris visible; size of pupil barely discernible: 3
Opaque cornea; iris not discernible through the opacity: 4
Maximum possible: 4
* The area of corneal opacity should be noted

Iris
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia;
or injection; iris reactive to light (a sluggish reaction is considered to be an effect: 1
Hemorrhage, gross destruction, or no reaction to light: 2
Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal: 0
Some blood vessels hyperaemic (injected): 1
Diffuse, crimson colour; individual vessels not easily discernible: 2
Diffuse beefy red: 3
Maximum possible: 3

Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal: 0
Some swelling above normal: 1
Obvious swelling, with partial eversion of lids: 2
Swelling, with lids about half closed: 3
Swelling, with lids more than half closed: 4
Maximum possible: 4

DEFINITIONS:
1. Eye irritation is the production of changes in the eye following the application of a test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
2.Eye corrosion is the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
within 7 days for all rabbits
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0.67
Max. score:
2
Reversibility:
fully reversible
Remarks:
Rabbit 1: 72 hours; Rabbit 2: 48 hours; Rabbit 3: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.89
Max. score:
3
Reversibility:
fully reversible
Remarks:
within 14 days for rabbit 1 and 3; within 7 days for rabbit 2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.44
Max. score:
4
Reversibility:
fully reversible
Remarks:
wihtin 7 days for all rabbits

Any other information on results incl. tables

Results

  Rabbit 1
Rabbit 2 Rabbit 3
1h 24h 48h 72h 7d 1h 24h 48h 72h 7d 1h 24h 48h 72h 7d
Corneal opacity 0 1 1 1 0 0 1 1 1 0 0 1 1 1 0
Iris 0 1 1 0 0 0 1 0 0 0 1 1 1
Conjunctival erythema 0 2 2 2 1 0 2 1 0 0 2 2 2 1
Conjuntival oedema 3 2 2 1 0 3 2 1 1 0 2 1 1

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Some irritating effects on all rabbits fully reversible within 14 days.
Executive summary:
The substance was tested for eye irritation according to the Real Decree 363/1995 is the transposition of Directive 67/548/EEC in Spanish legislation. Based on test results, the susbtance needs to be considered as eye irritant and required the hazard statement H319, Causes serious eye irritation.