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
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:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12-Nousan-8147 (2000)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Purity: >99%
Impurities: Not reported

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services, Inc. Mocksville, NC
- Age at study initiation: young adult
- Weight at study initiation: 2212 - 2481 g
- Housing:Individulally housed in suspended stainless steel caging with mesh floors with enrichment in each cage. Litter paper was placed beneath the cage and was changed at least 3x a week.
- Diet (e.g. ad libitum): ~150 g/day
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 52-70%
- Air changes (per hr): 12-13
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.07 g of the test substance
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
SCORING SYSTEM: numerical Draize technique

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 Hours
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
Mean Score
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
Mean score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not an irritant
Executive summary:

An eye irritation study was conducted with the test substance on 3 rabbits in a stepwise fashion in accordance with the OPPTS 870.2400 and OECD 405 Guidelines. Initially, one-tenth of a milliliter (0.07 g) of the test substance was instilled in the conjunctival sac of the right eye of one healthy rabbit. The left eye was used as the control. Occular irritaiton was scored using the numerical Draize method. Since irritation cleared within 24 hours and there was no significant irritation observed in the first animal, the test was completed on two additional animals to confirm the result.

There was no iritis observed in any treated eye during the study. Corneal opacity (score of 1) was observed in the treated eye of one rabbit, conjunctival redness (score of 1) and discharge (scores of 1 and/or 2) were observed in the treated eye of three rabbits, and chemosis (scores of 1 and/or 2) was noted in the treated eye of two rabbits. Irritation cleared in the treated eye of one rabbit at 24 hours and in the treated eye of the remaining two rabbits at 48 hours.