Registration Dossier
Registration Dossier
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EC number: 406-640-0 | CAS number: 136920-07-5 KEROFLUX ES 3241
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study is available from the original notifier since the substance was notified under NONS
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
- EC Number:
- 406-640-0
- EC Name:
- A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide
- Cas Number:
- 136920-07-5
- Molecular formula:
- Not applicable. Average Molecular Weight: Example Tetra-amide C150H300N6O4 = 2252 g/mol Average Molecular Weight : Based on the average molecular weight of the di-tallow amine starting material (mwt = 509 g/mol) = 2256 g/mol
- IUPAC Name:
- 2-[(2-{bis[(dioctadecylcarbamoyl)methyl]amino}ethyl)[(dioctadecylcarbamoyl)methyl]amino]-N,N-dioctadecylacetamide
- Details on test material:
- - Lot No.: T 75492/ST 1414/90, Part 1
- Physical state: solid, light beige; after heating at about 50°C: liquid, yellow
- Date of manufacturing: 1990-10-10
- Storage stability: at about 8°C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 3.22 kg (male), 3.28-3.96 kg (females)
- Housing: single in stainless steel cages with wire mesh walk floors
- Diet: KLIBA 341, 4 mm, Klingentalmuehle AG, Kaiseraugst, CH; 130 g/ day
- Water: tap water; 250 mL/ day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml of the test substance cooled down to body temperature
- Duration of treatment / exposure:
- Single application; the substance was not washed out
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Readings: 1 h, 24 h, 28 h, 72 h after application
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 -72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- Slight to moderate discharge was observed in 2 of the three tested animals which reversed fully within 72 h.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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