Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 March - 06 April 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an official US test guideline and the study conduct was well documented in the report; the study is considered reliable with restrictions, as there is no claim of GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- EC Number:
- 406-176-9
- EC Name:
- 2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
- Cas Number:
- 79072-96-1
- Molecular formula:
- Hill formula: C24 H30 O6
- IUPAC Name:
- 1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): NC-4
- Physical state: white powder
- Lot/batch No.: 399-P
- Storage condition of test material: Ambient temperature
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: 11 to 12 weeks.
- Weight at study initiation: 2.4 to 2.8 kg.
- Housing: Housed individually in metal cages with perforated floors.
- Diet (e.g. ad libitum): Free access to SDS Standard rabbit diet.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: The rabbits were acclimated to laboratory conditions prior to study start, but the duration was not specified.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approximately 19°C.
- Humidity (%): 30 - 70%.
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye in each animal was untreated and used as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg (the amount occupying a volume of 0.1 mL) - Duration of treatment / exposure:
- One second
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM:
Refer to "Any other information, below"
TOOL USED TO ASSESS SCORE: Handheld torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0 - 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: redness seen in 4 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0 - 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 1 day
- Remarks on result:
- other: Chemosis seen in two animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: Day 1 - 7
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: Day 1 - 7
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- other: Day 1 - 7
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: Day 1 - 7
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None of the animals gave a "positive" response.
No corneal damage or iridial inflammation was observed in any of the animals.
Transient mild conjunctival irritation was observed in four animals.
The eyes were normal 24 hours after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Instillation of NC-4 into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria.
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