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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:
26 Jun - 30 Jul 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
certified by Federal Office of Public Health, 2000

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Y-15099
- Physical state: pale yellow liquid
- Analytical purity: 99.6%
- Lot/batch No.: 18161-74
- Expiration date of the lot/batch: 2002-10-23
- Stability under test conditions: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: males: 10 - 11 weeks; females: 11 - 12 weeks
- Weight at study initiation: no data
- Housing: individually in stainless steel cages
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 90/01) provided by Provimi Kliba AG, CH-4303 Kaiseraugst
- Water: Community tap water from Füllinsdorf, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): automatically controlled light cycle of 12 hours light and 12 hours dark, music was played during the light period

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per animal
Duration of treatment / exposure:
single eye instillation
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): eyes were not rinsed after instillation

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean of readings at
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean value of readings at
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean value of readings at
Time point:
24/48/72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3/3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3/3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3/3
Time point:
24/48/72 h
Score:
0
Max. score:
2

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC), respectively.
Executive summary:

The primary eye irritation potential of Y-15099 was investigated in a GLP study according to OECD 405. Three young adult New Zealand White rabbits were exposed to the undiluted test item by instillation 0.1 mL into one eye. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test item application.

The instillation of the test item into the eye resulted in mild, early onset and transient ocular changes in all animals (observation time 1 hour after application). Observations included slight reddening and swelling of the conjunctivae and reddening of the sclera. These effects were reversible and were no longer evident 72 hours after treatment at termination. No abnormal findings were observed in the cornea or iris of any animal at any reading. No staining of the treated eyes by the test item was observed and no evidence of corrosion was evident at any of the measuring intervals. No classification is warranted according to DSD (67/548/EEC) and CLP (1272/2008/EC) classification criteria for eye irritation.