Registration Dossier
Registration Dossier
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EC number: 264-261-4 | CAS number: 63469-23-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-03-12 to 1979-03-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well documented non-GLP study performed similar to OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol
- EC Number:
- 264-261-4
- EC Name:
- 1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol
- Cas Number:
- 63469-23-8
- Molecular formula:
- C11H26N2O2
- IUPAC Name:
- 1-{[3-(dimethylamino)propyl](2-hydroxypropyl)amino}propan-2-ol
- Test material form:
- liquid
- Details on test material:
- Details described in study specific records
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): none used
- Sample number: 4236-21-35
- Substance type: Clear liquid
- Physical state: Liquid
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: local supplier
- Housing: The rabbits were housed two per cage in suspended wire mesh cages in temperature controlled room reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow was freely available
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 week
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye of each rabbit served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- No data; no washing after 24h
- Observation period (in vivo):
- The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days.
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- SCORING SYSTEM: Draize scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 45.8
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 48.6
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 67.8
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 14 days
- Score:
- 42.4
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- maximum mean total score (MMTS) measured instead
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- maximum mean total score (MMTS) measured instead
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- maximum mean total score (MMTS) measured instead
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- maximum mean total score (MMTS) measured instead
- Irritant / corrosive response data:
- Irritant response defined as 4 to 6 rabbits with positive scores.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Conclusions:
- The substance is defined as irritant to the eyes as 4 to 6 rabbits were observed to have positive scores. Based on these results and the fact that the substance is corrosive to the skin, the substance is classified as causing serious eye damage to eyes (category 1) according to CLP Regulation.
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