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EC number: 255-799-0 | CAS number: 42399-49-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 16- 19, 1998
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
- EC Number:
- 255-799-0
- EC Name:
- (2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
- Cas Number:
- 42399-49-5
- Molecular formula:
- C16H15NO3S
- IUPAC Name:
- (2S-cis)-2,3-dihydro-3-hydroxy-2-(4-methoxyphenyl)-1,5-benzothiazepin-4(5H)-one
- Details on test material:
- Characteristics: white powder
Storage conditions: room temperature in the original container
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The rabbits were about 2 -3 months old and weighed about 2.5 – 2.8 kg. All animals were clinically observed and 20% of them were weighed: their weight conformed to that required. The animals were housed in the same room in which the treatment was performed.
Animal room controls were set to maintain temperature and relative humidity at 19°C ± 2 and 55 ± 10, respectively. There were 15-20 air changes per hour. The room was illuminated by artificial lighting with a 12 hour circadian cycle (7 a.m. – 7 p.m.).
The diet was available “ad libitum” to the animals.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Dose administered: 0.1 g/animal
Administation route: ocular - Duration of treatment / exposure:
- about 3-4 seconds
- Observation period (in vivo):
- Observation of the eyes: 1,24,48 and 72 hours after the test article application. After the 24 hour reading, the cornea was examined after instillation of one drop of 1% sodium fluorescein and successive washing out with sterile saline solution.
- Number of animals or in vitro replicates:
- Number and sex of animals: 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48-72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 60 minutes, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 60 minutes, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 60 minutes, 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Slight conjuntival redness was noted in all rabbits at the reading carried out 1 hour after exposure.
At the subsequent observation, 24 hours later, the same change was still noted in two animals.
Negative results were obtained at the fluorescein staining performed at this time.
No ocular changes were subsequently observed.
Mortality and clinical signs: Neither mortality nor adverse general clinical modifications were seen during the study.
No general clinical signs were noted in any rabbit. Locally, at the application site, slight ocular changes consisting of conjunctival redness were noted up to 24 hours after exposure.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article DTZ62 administered to rabbits as a single ocular application, i sto be considered “non irritant” for the eye.
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