Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-01-27 to 2009-02-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
, 2008
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, 2002-04-24
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Chemical name: (I)-Methyl-N-ethyloxamat
- Molecular formula: C14H25NO3
- Molecular weight: 255.36g/mol
- Physical state: colourless, viscous oil
- Storage condition of test material: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
-SPF albino rabbits, stock Chbb:HM
- Source: Charles River Deutschland GmbH, D-88353 Kißlegg
- Age at study initiation: approx. 21 to 46 month
- Weight at study initiation: 2.7 to 2.9 kg bw
- Housing: the animals were individually housed in PPO cages
- Diet (ad libitum): a complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe
- Water (ad libitum): bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Humidity: 30 to 70 %
- Air changes: 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml of the test item was placed in one eye of each rabbit.
Duration of treatment / exposure:
not applicable
Observation period (in vivo):
1, 24, 48, 72 hours after the administration
Number of animals or in vitro replicates:
three female rabbits (Initial, a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.)
Details on study design:
The day before testing both eyes of the animals were examined with a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2 X magnification to ensure there were no defect or irritation. The examination was performed before and after the instillation of Fluorescein.

Test item was placed by gently pulling the lower lid away from the eyeball and put the test item into the conjunctival sac. The lids were then gently held together for one second. The other eye remained untreated and served as a control. A first only one rabbit was exposed in one eye during an initial test. Based on findings two more rabbits were treated with 0.1 ml of the test item each.
The treated eyes were examined and the grade of ocular reaction were recorded 1 hr and 24 hr later. After 24-hour-reading Fluorescein was instilled. After irrigation with 20 ml 0.9% sodium chloride the eyes were examined again using UV-light to detect possible corneal damage. The examination was performed before and after the instillation of Fluorescein. The eyes were also examined 48 hrs and 72 hrs after the treatment.

SCORING SYSTEM: according to the Draize scale

TOOL USED TO ASSESS SCORE: hand held inspection lamp fitted with white and UV-light and with 2x magnification

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
One hour after the application of the test item all animals showed some hyperaemic conjunctival blood vessels and a swelling above normal.
24 hours after the application of the test item some hyperaemic conjunctival blood vessels and a swelling above normal were observed in all animals. After instillation of Fluorescein all animals did not show any ocular reaction.
48 hours and 72 hours after the application of the test item the animals were free of any signs of eye irritation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is non-irritating to the eye.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as an eye irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as an eye irritant.