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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:
key study
Study period:
19 July - 19 August, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 2053.4 g, 1792.4 and 1829.0 g
- Housing: single, in steel cages with a plastic bottom mould and a habitat of 5445 cm2 at the bottom and an overall height of 600 mm.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): set at 20 +/- 3°C, but temperature was actually between 23-30 °C due to extreme outdoor temperature.
- Humidity (%): set at 40-70 %.
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 26 July 2004 To: 3 August 2004

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye remained untreated and served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): not applicable
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1h, 24h, 48h, 72h and 7 days after application
Number of animals or in vitro replicates:
3 (2 females and 1 male)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after observation at 24 hours, the eyes were examined with the aid of 0.5 % (w/v) fluorescein in saline solution which was washed off 30 seconds later with saline solution.
- Time after start of exposure: after 24 h

SCORING SYSTEM: according to OECD405. The Primary Irritation Index was calculated from the numerical scores for cornea, iris and conjunctivae according to the following scheme:
- cornea: opacity x area x 5 = max. 80
- iris: iris x 5 = max. 10
- conjunctivae: (redness + chemosis + discharge) x 2 = max. 20

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Remarks:
opacity and area
Basis:
mean
Remarks:
three animals
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
three animals
Time point:
other: 24, 48 and 72 h
Score:
0
Other effects:
No systemic toxic symptoms were observed. Body weight gain was positive and normal for two animals. Body weight gain was negative for one female, probably due to competition of the two females housed together. At the end of the study both females were of about equal body weight. The weight loss is supposed not to be substance related.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Using the Draize Primary Irritation Index the substance is graded as 'non-irritating' to the eyes. According to the EU criteria, the substance does not have to be classified for eye irritation.
Executive summary:

The eye irritation potential of the substance was assessed by a single application of the substance into the lower conjunctival sac of two female and one male rabbit, strain New Zealand White, according to OECD Guideline 405. 0.1 ml of test substance was applied. Occular reactions were assessed 1, 24, 48, 72 hours and 7 days after application of the substance.

Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was within normal ranges.

All three animals showed showed a minor occular reaction (conjunctivae redness 1 score, conjunctivae chemosis 1 score) 1 hour after application of the substance. At 24 hours after the application not any effect of the substance toward the eye could be observed.