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EC number: 605-076-4 | CAS number: 156928-09-5
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Acute Toxicity
- Irritation / corrosion
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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:
- 2007-03-28 to 2007-04-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 405 (Acute Eye Irritation / Corr and EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) without deviation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
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
- Remarks:
- Certificate issued by the Swiss GLP monitoring authorities
Test material
- Reference substance name:
- (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-ol
- EC Number:
- 605-076-4
- Cas Number:
- 156928-09-5
- Molecular formula:
- C6H10O3
- IUPAC Name:
- (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-ol
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study reports): T002675, TIC876
- Physical state: liquid
- Appearance: colorless to yellowish liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 603T-1
- Expiration date of the lot/batch: 2007-12-19
- Purity test date: no data
- Purity: 97.76%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was applied undiluted as it was delivered by the sponsor
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: 3 male and 3 female young adult New Zealand White Rabbits; Harland Netherlands BV, Kreuzelweg 53, NL-5961 NM Horst, The Netherlands; Postbus 6174, NL-5960 AD Horst, The Netherlands
- Age at study initiation: 11-12 weeks for males; 11-13 weeks for females
- Weight at study initiation: 2082-2271 g
- Housing: standard laboratory conditions; individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 4642 batch no.08/07 were provided for gnawing.
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch 01/07), ad libitum
- Water (e.g. ad libitum): Füllinsdorf community tap water, ad libitum
- Acclimation period: 5 days, under laboratory conditions after health examination. Only animals without any visual signs of illnes were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): approximately 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.
IN-LIFE DATES: From: 2007-04-02 To: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): test item was applied undiluted - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48, 72 hours, as well as 7 days after administration.
- Number of animals or in vitro replicates:
- 3 (1 male, 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM:
- The eye reactions were assessed according to the numerical scoring system listed in the Commission Directive 2004/731EC, April 29, 2004. Scleral reddening and ocular discharge were also assessed.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- : redness
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- : redness
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- : redness
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: same score- all 3 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: same score- all 3 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable - score 0
- Irritant / corrosive response data:
- - No abnormal findings in the cornea or iris of any animal at any time.
- A slight to moderate reddening of the conjunctivae was noted in all animals 1 hour after instillation, and persisted up to 48 hours in the male and 72 hour in the females.
- Slight to moderate swelling of the conjunctivae was noted at the 1 hour observation that persisted to 24 hours.
- All animals had slight to moderate reddening of the sclera, 1-48 hours in the male, to 72 hours in the females, and slight to moderate discharge was present 1 to 24 hours after instillation in all animals.
- No abnormal findings were observed in the treated eye of any animal 7 days after treatment, the end of the observation period for all animals. - Other effects:
- VIABILITY/MORTALITY
- No clinical signs of systemic toxicity were observed, and no mortality occurred during the study.
COLORATION
- No staining of the treated eyes by the test item was observed.
CORROSION
- No corrosion of the cornea was noted at any of the observation times.
BODY WEIGHTS
- The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Eye Irritation Scores - Individual Values |
||||||||
Animal Number |
Sex |
Evaluation Interval |
Corneal Opacity |
Area of Corneal Opacity |
Iris |
Conjunctivae |
Sclera |
|
Redness |
Chemosis |
|||||||
4 |
M |
1 hour |
0 |
0 |
0 |
1 |
2 |
1 |
5 |
F |
0 |
0 |
0 |
1 |
2 |
1 |
|
6 |
F |
0 |
0 |
0 |
1 |
2 |
2 |
|
4 |
M |
24 hours |
0 |
0 |
0 |
1 |
1 |
1 |
5 |
F |
0 |
0 |
0 |
2 |
1 |
2 |
|
6 |
F |
0 |
0 |
0 |
1 |
1 |
2 |
|
4 |
M |
48 hours |
0 |
0 |
0 |
1 |
0 |
1 |
5 |
F |
0 |
0 |
0 |
1 |
0 |
1 |
|
6 |
F |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
M |
72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
1 |
0 |
1 |
|
6 |
F |
0 |
0 |
0 |
1 |
0 |
1 |
|
4 |
M |
7 days |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
F |
0 |
0 |
0 |
0 |
0 |
0 |
|
* Examinations were performed at the specified times after instillation of the test item. |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the reffered classification(Commission Directive 2001/59/EC of August 06, 2001), T002675 is considered to be "not irritating" to the rabbit eye.
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