Registration Dossier
Registration Dossier
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EC number: 245-883-5 | CAS number: 23783-42-8
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,6,9,12-tetraoxotridecanol
- EC Number:
- 245-883-5
- EC Name:
- 3,6,9,12-tetraoxotridecanol
- Cas Number:
- 23783-42-8
- Molecular formula:
- C9H20O5
- IUPAC Name:
- 2,5,8,11-tetraoxatridecan-13-ol
- Test material form:
- liquid
- Details on test material:
- - Physical state: colorless 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: Hoechst AG, Box reason, conventional breeding
- Age at study initiation: 3 - 5 Months
- Weight at study initiation: 3.1 - 4.4 kg
- Housing: in air-conditioned rooms in individual cages (Battery cages)
- Diet: Altromin 2123 Haltungsdiat - rabbits Altromin GmbH, Lage / Lippe, ad libitum and hay (about 15g daily)
- Water: deionized, chlorinated water from autonomic watering, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 50 +/- 20%
- Photoperiod: 12 hours a day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye in each case served as a control
- Amount / concentration applied:
- 0.1 ml of methyltetraglycol was given as a single dose in the conjunctival sac of the left eye.
- Observation period (in vivo):
- The assessments of the eyes were made 1, 24, 48 and 72 hours after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
Any other information on results incl. tables
An hour after the administration revealed the conjunctiva and slight swelling markedly injected blood vessels. 24 hours post-administration the conjunctiva of two animals showed distinct hyperemia of blood vessels and diffuse staining crimson were observed. 48 post-adiminstration all irritative symptoms had fully reversed.
Individual findings |
| Time post application | 1h | 24h | 48h | 72h |
| Animal number | 1 2 3 | 1 2 3 | 1 2 3 | 1 2 3 |
| Conjunctival swelling | 1 1 0 | 0 0 0 | 0 0 0 | 0 0 0 |
| Conjunctival redness | 1 1 1 | 2 0 1 | 0 0 0 | 0 0 0 |
| Iris | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
| Cornea | 0 0 0 | 0 0 0 | 0 0 0 | 0 0 0 |
| Fluorescein Test | 0 0 0 | 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Executive summary:
In a guideline eye irritation study using the substance methyltetraglycol, no corneal, iris or chemosis response was seen. Slight conjunctival redness was seen with an average score of 0.33 across the three observation timepoints of 24, 48, and 72 hours, but these effects fully resolved across all three animals by the time of the 48 hour observation. On this basis, the substance is regarded as not irritating for classification purposes.
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