Registration Dossier
Registration Dossier
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EC number: 203-812-5 | CAS number: 110-88-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Remarks:
- (Hoechst AG, Toxicology and Pathology)
Test material
- Reference substance name:
- 1,3,5-trioxane
- EC Number:
- 203-812-5
- EC Name:
- 1,3,5-trioxane
- Cas Number:
- 110-88-3
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 1,3,5-trioxane
- Details on test material:
- - Name of test material (as cited in study report): Trioxane
- Physical state: crytals
- Analytical purity: 99.1 %
- Impurities (identity and concentrations): ca. 0.1 % Triethanolamine, ca. 0.8 % water
- Storage condition of test material: 4 °C in dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.3-2.7 kg
- Diet (e.g. ad libitum): Altromin 2123 diet
- Water (e.g. ad libitum): deionized water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 1 week
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline (37 °C)
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 rabbits
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24-48-72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
