Registration Dossier
Registration Dossier
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EC number: 807-033-7 | CAS number: 55258-21-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- - According to [Hygienic Standard for Cosmetics] issued by the Ministry of Health of People’s Republic of China 2007.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 807-033-7
- EC Number:
- 807-033-7
- IUPAC Name:
- 807-033-7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 2.5 - 3.0 kg
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 60-70%
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 2% - Duration of treatment / exposure:
- The eye of the rabbit was flushed 30 seconds after sample application.
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1, 24, 48 and 72 hr
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1, 24, 48 and 72 hr
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1, 24, 48 and 72 hr
- Score:
- 0
- Irritant / corrosive response data:
- There was no ocular irritation observed in any animal at any time point.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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