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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Sep 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Purity: 100 % (according to data of the sponsor)
- Storage condition of test material: refrigerator

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Crl:KBL(NZW)BR
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2.6-2.8 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
Amount: 0.1 mL

Observation period (in vivo):
1, 24, 48, 72 hours post application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The trated eye was rinsed approximately 24 hours following instillation with 0.9 % saline

SCORING SYSTEM: according to DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1,2,3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
iris score
Basis:
animal: #1,2,3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
conjunctivae score
Basis:
animal: #1,3
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0 - 2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1.0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 day in respect of the result 1 hour post application
Remarks on result:
other: mean score after 72 hours: 0.0
Irritation parameter:
chemosis score
Basis:
animal: #2,3
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3

Any other information on results incl. tables

Table 1: Summary of irritant effects on the eye

 

Observation time           1h  24h  48h  72h  day7 day14 day21
Animal 1
Degree of cornea opacity    0   0    0    0    -     -     -     
Area of cornea opacity      0   0    0    0    -     -     -     
Iris                        0   0    0    0    -     -     -     
Redness conjunctivae        1   1    0    0    -     -     -     
Chemosis conjunctivae       1   0    0    0    -     -     -     
Animal 2
Degree of cornea opacity    0   0    0    0    -     -     -     
Area of cornea opacity      0   0    0    0    -     -     -     
Iris                        0   0    0    0    -     -     -     
Redness conjunctivae        2   2    1    0    -     -     -     
Chemosis conjunctivae       1   1    0    0    -     -     -     
Animal 3
Degree of cornea opacity    0   0    0    0    -     -     -     
Area of cornea opacity      0   0    0    0    -     -     -     
Iris                        0   0    0    0    -     -     -     
Redness conjunctivae        2   1    0    0    -     -     -     
Chemosis conjunctivae       1   1    0    0    -     -     -    

- = no further examination

           

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:



Classification: not irritating
Executive summary:

In an eye irritation study according to OECD TG 405 the substance was instilled into the conjunctival sac of one eye of 3 female rabbits. Eye irritation was assessed after 1, 24, 48 and 72 hours using the Draize scale. In this study the substance shows slight irritant effects (mean irritation indices: redness conjunctivae = 0.5, chemosis conjunctivae = 0.2) which were fully reversible within 3 days. No irritation effects were seen at cornea or iris 24 hours after instillation. The weight of these evidences indicates that the test substance may be considered as "slightly irritating to the eyes". No systemic intolerance reactions were observed.

According to classification criteria the substance is not an irritant to the eyes.