Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-06-11 to 2007-07-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
April 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
April 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
D-Glucose, ether with glycerol
EC Number:
309-496-6
EC Name:
D-Glucose, ether with glycerol
Cas Number:
100402-60-6
Molecular formula:
C9H18O8, small ammounts of C15H28O13 and C21H38O18 (UVCB)
IUPAC Name:
(3R,4S,5S,6R)-2-(2,3-dihydroxypropoxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (3R,4S,5S,6R)-2-(3-hydroxy-2-{[(3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}propoxy)-6-(hydroxymethyl)oxane-3,4,5-triol; (3R,4S,5S,6R)-2-[2,3-bis({[(3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})propoxy]-6-(hydroxymethyl)oxane-3,4,5-triol

Test animals / tissue source

Species:
rabbit
Strain:
other: white albino; strain: Chbb:HM
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH; Stolzenseeweg 32-36; D-88353 Kißlegg, Germany
- Age at study initiation: approx. 10 to 12 months
- Weight at study initiation: 2.6 - 2.9 kg
- Housing: individually in PPO cages (floor area 2576 sq.cm) with perforated floor
- Diet: pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe; Germany, ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 to prevent microbial growth, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12 from 6 am to 6 pm

IN-LIFE DATES: From: 2007-06-11 To: 2007-06-23

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes; with 20 mL 0.9 % sodium chloride solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to the guidelines stated in Directive 2001/59/EEC of August 6th, 2001

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(3811)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(3883)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(3885)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(3811)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(3883)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(3885)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(3811)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
1
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(3885)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.22
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(3811)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(3883)
Time point:
other: 24,48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(3885)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Based on the results of the study, the test item is not classified as eye irritating.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions the test item was not irritating to the eyes.
Executive summary:

The test item was investigated for its eye irritation potential in accordance with OECD guideline 405 under GLP compliance. Only minimal conjunctiva irritation was observed in all animals which was fully reversible within 48 hours. The test substance has no potential for eye iritation in this test.