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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From November 18 to 25, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The complete read across justification is detailed in section 13. Source study has reliability 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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: Kleintierfarm Madoerin AG 4414 Fuellinsdorf / Switzerland
- Age at study initiation: ca. 14 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: animals were caged individually in stainless steel cages with automatic drinking water supply and cleaning system
- Diet: pelleted standard Kliba 23/341/1, rabbit maintenance diet defined for acceptaeble contaminant level, ad libitum
- Water: tap water, ad libitum.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours cycle dark/light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g to the left eye of each animal
Duration of treatment / exposure:
single application into conjunctival sac
Observation period (in vivo):
1, 24, 48, 72 hours after treatment.
Number of animals or in vitro replicates:
3 rabbits (1 male and 2 females)
Details on study design:
SCORING SYSTEM: Draize J.H. 1959
Cornea opacity and degree of density (most dense area scored)
0 no opacity
1 scattered or diffuse area, details of iris clearly visible
2 easily discernible translucent areas, details of iris slightly obscured
3 opalescent areas, no details of iris visible, siz eof pupils barely discernible
4 opaque, iris invisible

Iris
0 normal
1 folds above normal, congestion, swelling, circumcornea injection (nay or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, hemorrage, gross destruction (any or all of these)

Conjunctivae redness (refers to palpebral and bulbar conjunctiva excluding cornea and iris)
0 vessels normal
1 vessels definitely injected above normal
2 more diffuse, deeper crimson red, individual vessels not easily discernible
3 diffuse beefy red

Conjuctivae chemosis
0 no swelling
1 any swelling above normal (includes nictitating membrane)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half closed
4 swelling with lids about half to completely closed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: all
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no eye reaction observed
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal: all
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Reversibility:
other: no eye reaction observed
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: all
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Reversibility:
other: no eye reaction observed
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal: all
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: no eye reaction observed
Remarks on result:
other: not rinsed
Other effects:
No discoloration of the cornea and conjunctivae was observed in the rabbits during the entire test period, which could be related to compound effects.
No acute toxicological signs were observed in the rabbits during the test period.

Any other information on results incl. tables

Upon sacrifice, no macroscopical organ examination was indicated, due to the results obtained.

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
Under test conditions, test substance was found to cause no irritation when applied to the rabbit eye mucosa.
Executive summary:

Method

The substance was evaluated for eye irritation/corrosion according to the OECD guideline 405. Test substance was applied to the left eye of each animal and the eye was not rinsed. The right eye served as control.Reactions were scored 1 hour, 24, 48 and 72 hours after application.

Results

Under test conditions, the substance was found to cause no irritation when applied to the rabbit eye mucosa. No discoloration of the cornea and conjunctiva, which could be related to compound effect was observed. No corrosion effect was observed at each of the measuring intervals.