Registration Dossier
Registration Dossier
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EC number: 947-942-7 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylhexyl (6-isocyanatohexyl)-carbamate
- EC Number:
- 247-735-5
- EC Name:
- 2-ethylhexyl (6-isocyanatohexyl)-carbamate
- Cas Number:
- 26488-60-8
- Molecular formula:
- C16H30N2O3
- IUPAC Name:
- 6-Isocyanatohexylamino 3-ethylheptanoate
- Reference substance name:
- Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate
- EC Number:
- 278-583-8
- EC Name:
- Bis(2-ethylhexyl) 1,6-hexan-1,6-diylbiscarbamate
- Cas Number:
- 76977-79-2
- Molecular formula:
- C24H48N2O4
- IUPAC Name:
- 6-(2-Ethylhexyloxycarbonylamino)hexylamino 3-ethylheptanoate
- Reference substance name:
- Hexamethylene diisocyanate
- EC Number:
- 212-485-8
- EC Name:
- Hexamethylene diisocyanate
- Cas Number:
- 822-06-0
- Molecular formula:
- C8H12N2O2
- IUPAC Name:
- 1,6-diisocyanatohexane
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Sex: male
- Source: LPT, 24601 Loehndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 3.5 months
- Weight at study initiation: 1.8-2.4 kg
- Housing: singly
- Diet and water: ad libitum
- Acclimation period: at least 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye, which remained untreated, served as a control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- CONDUCT
A dose of 0.1 mL test substance was administered into the conjunctival sac of the right eye of rabbits after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one second in order to prevent loss of test material.
EXAMINATIONS
The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48, and 72 hours after the administration. 24 hours after administration, the eyes were treated additionally with fluorescein and examined.
SCORING SYSTEM
Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
Under the present test conditions, a single application of 0.1 mL per animal into the conjunctival sac of the right eye of three rabbits caused the following effects:
Conjunctival redness (grade 1) was observed in animal nos. one and two 1 hour after instillation.
The cornea and the iris were not affected by instillation of the test compound.
There were no systemic intolerance reactions.
Applicant's summary and conclusion
- Executive summary:
For the assessment of eye irritation a study according to OECD TG 405 is available. In this study 0.1 mL of the unchanged test substance was instilled in the conjunctival sac of the lower lid of each of three rabbits. Examination of the eyes revealed 1 hour after dosing conjunctiva (redness) score 1 in 2/3 animals. All changes were resolved 24 hours post application at the latest (all 24, 48 and 72 -hour scores zero).
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