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EC number: 226-159-8 | CAS number: 5306-85-4
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- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Mar - 14 Apr 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 24 Apr 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- EC Number:
- 226-159-8
- EC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
- Cas Number:
- 5306-85-4
- Molecular formula:
- C8H14O4
- IUPAC Name:
- 1,4:3,6-dianhydro-2,5-di-O-methyl-D-glucitol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: CEGAV breeding establishment, Passais la Conception, France
- Age at study initiation: 9 -12 weeks
- Weight at study initiation: 2.552 - 3.387 kg
- Housing: individually in cages of standard size
- Diet: SDS/DIETEX STANRAB (P) SQC feed, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 21
- Humidity (%): 45 -65
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 8 days
Reading time points: 1 h after instillation and on Day 2, 3, 4, 5 and 8 (The day of instillation was taken as the first study day/ Day 1.) - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: Confirmation of the presence of corneal damage was carried out (except for reading at time one hour) by examination after instillation of a 0.5 to 2% aqueous solution of sodium fluorescein and rinsing with sterile and pyrogen free isotonic saline (generally 10 mL); Lesions of the conjunctiva, iris and cornea were monitored by direct examination.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- Slight chemosis and lacrimation were observed in all animals 1 hour after instillation of the test substance. All animals had slight to moderate conjuctiva redness (score 1 to 2) one hour after instillation which persisted in one animal up to Day 2, in second animal up to Day 3 and in third animal up to Day 4. No lesions of the iris were observed during the study. One animal had slight opacity of the cornea greater than three-quarters of the area, up to whole area until day 2. In two other animals, slight opacity involved greater than half but less than three quarters of the cornea one hour after instillation and greater than one quarter but less than half of the cornea on Day 2.
- Other effects:
- - Other observations: No abnormality was seen in body weight gain.
Any other information on results incl. tables
Table 1: Results of the eye irritation study.
Observations (range of scores; normal score) |
Animal No. |
Time (h) after instillation |
|||||
1 |
24 |
48 |
72 |
mean 24/48/72 h |
reversible within |
||
Cornea (0-4; 0) |
1 |
1 |
1 |
0 |
0 |
0.33 |
48 h |
2 |
1 |
1 |
0 |
0 |
0.33 |
48 h |
|
3 |
1 |
1 |
0 |
0 |
0.33 |
48 h |
|
Area of Cornea involved (0-4; 0) |
1 |
4 |
4 |
0 |
0 |
1.33 |
48 h |
2 |
3 |
2 |
0 |
0 |
0.67 |
48 h |
|
3 |
3 |
2 |
0 |
0 |
0.67 |
48 h |
|
Iris (0-2; 0) |
1 |
0 |
0 |
0 |
0 |
0.00 |
- |
2 |
0 |
0 |
0 |
0 |
0.00 |
- |
|
3 |
0 |
0 |
0 |
0 |
0.00 |
- |
|
Conjunctivae Redness (0-3; 0) |
1 |
1 |
1 |
1 |
0 |
0.67 |
72 h |
2 |
1 |
2 |
2 |
1 |
1.67 |
4 days |
|
3 |
1 |
2 |
0 |
0 |
0.67 |
48 h |
|
Conjunctivae Chemosis (0-4; 0) |
1 |
1 |
0 |
0 |
0 |
0.00 |
24 h |
2 |
1 |
0 |
0 |
0 |
0.00 |
24 h |
|
3 |
1 |
1 |
0 |
0 |
0.33 |
48 h |
|
Lacrimation (0-3; 0) |
1 |
1 |
0 |
0 |
0 |
0.00 |
24 h |
2 |
1 |
0 |
0 |
0 |
0.00 |
24 h |
|
3 |
1 |
0 |
0 |
0 |
0.00 |
24 h |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.
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