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EC number: 604-604-0 | CAS number: 147770-06-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 27, 1998 - Jan. 1, 1999
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
- EC Number:
- 604-604-0
- Cas Number:
- 147770-06-7
- Molecular formula:
- C29 H40 N2 O4
- IUPAC Name:
- 2-Ethoxy-4-{3-[(S)-3-methy-1-(2-piperidin-1-yl-phenyl)-butylamino]-2-oxo-propyl}-benzoic acid ethyl ester
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- New Zealand White Rabbits Crl:KBL (NZW) BR.
3 female animals were used. Body weight at the commencement of the study:
3.1 kg, 3.7 kg, 3.7 kg
The animals were derived from a controlled full barrier maintained breeding
system (spf).
Source: Charles River Deutschland GmbH, D-88353 Kif3legg.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals
are bred for experimental purposes.
- Semi-barrier in air conditioned rooms
- Temperature: 18 ± 3 °C
- Rel. humidity: 55 ± 10%
- Artificial light, lighting regime 12 : 12 hours, light 6.30 - 18.30
- Air change:at least 10 x / hour
- Free access to Altromin 2123 maintenance diet rabbit,
rich in crude fibre, totally pathogene free-TPF
- Free access to tap water ( drinking water, municipal residue control,
microbiol. controlled periodically)
- Individually housed in ABS - plastic rabbit cages, floor 4200 cm2
- Acclimatization period 1 week
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 96h
- Number of animals or in vitro replicates:
- 3 female rabbits
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:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.89
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal lesions were found upon fuorescin examination at 96 h
- Other effects:
- no other
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified acc. to CLP
- Conclusions:
- Considering the reported data of this irritation study it can be stated that the
test item caused slight irritation but no corrosive effects to the eyes o f albino
rabbits.
According to Directive 93/21 EEC the labelling of the test item as an eye
irritant is not required. - Executive summary:
In this eye irritation study the test item AGEE 623 Amiclester was applied to
the lower conjunctiva! sac of one eye of 3 NZW - rabbits (Crl :KBL (l\ZW)
BR) at a close of 0.1 g per application site. The untreated other eye served as
control.
Observations were compared to the control eyes, I h, 24 h, 48 h, 72 and 96
hours after application of the test item.
The eyes were not rinsed after 24 hours.
The test item caused slight to distinct erythema and a slight oedema of the
conjunctivae in all animals lasting up to 72 h after application. No changes
were visible at the 96 h reading in any of the 3 test animals.
No corneal lesions were found upon fluorescein examination at the 96 h reading.
The total mean cumulative scores of the 24, 48 and 72 hour readings did not
exceed the limit values according to Directive 93/21 EEC in any case.
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