Registration Dossier
Registration Dossier
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EC number: 605-301-6 | CAS number: 162691-59-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 405 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Asta-C15-acetal (C15-Acl)
- IUPAC Name:
- Asta-C15-acetal (C15-Acl)
- Reference substance name:
- 94/29
- IUPAC Name:
- 94/29
- Details on test material:
- - NAME OF TEST SUBSTANCE: ASTA-C15-ACETAL (C15-ACL)
- SUBSTANCE NUMBER: 94/29
- LOT NUMBER: 25656/133 S
- DATE OF MANUFACTURING: 07-FEB-1994
- PHYSICAL STATE/APPEARANCE: LIQUID, OILY, YELLOW
- STORAGE CONDITIONS: ROOM TEMPERATURE, EXCLUSION OF LIGHT
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach a. Main, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.90 - 3.24 kg
- Housing: single in stainless steel wire mesh cages with grating, floor area: 3,000 cm2
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day).
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eyes.
- Amount / concentration applied:
- Application volume: 0.1 mL (unchanged).
- Duration of treatment / exposure:
- 72 h, since no wash out was done.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 female animals.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was performed
SCORING SYSTEM: as described in OECD Guideline 405 (cornea opacity, conjunctivae redness, chemosis and iris).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- iris score
- Basis:
- other: animal #1, #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: individual scores: 0 - 0 - 0
- Irritation parameter:
- chemosis score
- Basis:
- other: animals #2 and #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 1 - 0 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 2 - 1 - 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: individual scores: 2 - 0 - 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the test conditions chosen and considering the described findings Asta-C15-acetal does not give indication of an irritatnt property to the eye. Thus, classification is not warranted according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.
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