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
Study period:
3 March 1999 - 21 June 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Covance research products, Inc., Denver, PA.
- Age at study initiation: young adult
- Weight at study initiation: 3898 to 4295g
- Housing: individual suspended wire mesh cages
- Diet: PMI Nutrition International, Inc. Certified Rabbit Lab Diet 5322, at ca. 150g/day
- Water: reverse osmosis treated municipal water, ad libitum
- Acclimation period: minimum 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3-18.8
- Humidity (%): 43.8-60.5
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated eye.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 ml

- Concentration (if solution): undiluted
Duration of treatment / exposure:
Single instillation, not rinsed.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): Not rinsed.

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: sodium fluorescein and UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.7
Max. score:
1
Irritant / corrosive response data:
There were no positive ocular findings noted during the study. All animals had minor conjunctival irritation that had completely subsided by day 3.

Any other information on results incl. tables

No death or significant body weight changes were observed. No corneal or iridal reactions were noted.  Minor
conjunctival reactions were noted in the treated eye of all animals.  Conjunctival irritation subsided in 1 animal by
day 2 and two animals by day 3. Redness was observed in two animals up to 48 hours, and in one animal up to 24 hours.
Discharge was noted in one animal at 1 hour. Mean scores at the 1, 24, 48 and 72 hour time points were, 2.7, 2.0, 1.3
and 0.0, respectively. A maximum average score of 2.7 was calculated at the one-hour time point, indicating that A-172
was a mild irritant to the rabbit eye under the exposure conditions employed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be a mild irritant, as determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP. The observed effects do not meet the criteria for classification as an eye irritant in the EU.