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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:
Nov 2003- Dec 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Title:
Unnamed
Year:
2003
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor, 2003 7026
- Expiration date of the lot/batch: 31-Dec-2013
- Purity test date: > 99%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20+/- 3°C), in closed containers in the dark

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
0.1 g (per animal) of ADN was weighed and applied undiluted as it was delivered by the Sponsor.
The pH of the test item was measured for a prevoius study ans was found to be 6.

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
- Age at study initiation: 11 wks (male), 11-12 wks (female)
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch n. 52/03).
- Water (e.g. ad libitum): Communitu tap water from Fuellinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
24, 48, 72 hours
Observation period (in vivo):
daily
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 2, 3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Remarks on result:
probability of weak irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Other effects:
Np staining of the treated eyes produced by the test item was observed.
No abnormal findings were observed in the treated eye of any animal 10 days (1 animal) and 14 days (2 animals) after treatment.
the maximum duration of any effect can be detailed as follows:
redness - 10 days
chemosis - 48 hrs
cornea - 24 hrs
iris - 24 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification (Commision Directive 2001/59/EC of August 06, 2001), ADN is considered to be "not irritating" to the rabbit eye.