Registration Dossier
Registration Dossier
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EC number: 947-436-6 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Followed Appraisal for the saftey of chemicals in food, drugs and cosmetics, FDA and Draize 1959
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
- EC Number:
- 947-436-6
- Molecular formula:
- not applicable for UVCB
- IUPAC Name:
- Reaction product of tetrahydro-2,5-dimethoxy furan, ethanol and water
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 2.4-2.6 kg
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period:not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-1
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% in water - Observation period (in vivo):
- 1, 2, 8 h after treatment, as well as 1, 2, 3, 4, 5, 6, and 7 d after treatment
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 19.3
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 14.2
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Accoridng to the effects observed in the eye of the rabbit the test substance is considered a weak irritant to eyes.
- Executive summary:
The substance was applied to the eye of albino rabbits. Slight effects were observed (cornea was unaffected, iris showed slight effects, Conjunctivae showed chemosis and secretion).
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