Registration Dossier
Registration Dossier
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EC number: 939-581-9 | CAS number: 1471314-81-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2006-02-14 - 2006-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- 3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
- EC Number:
- 939-581-9
- Cas Number:
- 1471314-81-4
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- 3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): OXIDET L-75
- Substance type: surfactant, generator of foam and stabiliser
- Physical state: Liquid
- Isomers composition: Nor applicable
- Lot/batch No.: Pha007.1168
- Storage condition of test material: 20±5ºC and in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunícula San Bernardo, S.L
- Age at study initiation: 13-14 weeks
- Weight at study initiation: 2.8 kg
- Housing: in a stainless steel cage with a grille floor and placed on a rack
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 40-65%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- The treated eye was washed with physiological saline solution at one hour after administration
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: neovascularization and growth of the surface tissue over cornea
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- hyperaemia
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: bloody aspect of conjunctiva and nictitating membrane at 1h
- Irritation parameter:
- conjunctivae score
- Remarks:
- edema
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritant / corrosive response data:
- After 1 h: scattered or diffuse areas of corneal opacity (grade 1); conjunctiva and the nictitating membrane presented a bloody aspect, conjunctiva showed diffuse beefy colouring (grade 3) and swelling with lids more than half closed (grade 4); lacrimation with moistening of the lids and adjacent fur with bloody aspect (grade 2); iris could not be examined.
After 24, 48, 72h: similar effects as after 1 h.
After 7 days: easily discernible translucent area in the cornea (25-50% of the area) and neovascularization; diffuse beefy colouring in the conjunctiva, swelling with the lids half closed; lacrimation with moistening of the lids and adjacent fur.
After 14 and 21 days: nacreous area of opacity in the cornea (75-100% of the area) and neovascularization; diffuse crimson colouring in the conjunctiva, swelling with the lids half closed; lacrimation with moistening of the lids and adjacent fur and whitish secretion.
After 21 days: growth of the surface tissue over the cornea.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance is considered to be classified as serious eye damage 1 according to CLP regulation.
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