Registration Dossier
Registration Dossier
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EC number: 701-381-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 970
- Report date:
- 1970
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- small volume of test substance (0.05 ml)
- GLP compliance:
- no
Test material
- Reference substance name:
- Amines, C11-C13 (linear and branched) alkyl
- EC Number:
- 701-381-2
- IUPAC Name:
- Amines, C11-C13 (linear and branched) alkyl
- Details on test material:
- - Tridecylamine technical grade
- Purity approx. 95%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 2.9 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye of the same animal treated with NaCl
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.05 ml
- Concentration: undiluted - Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM:
Eye reactions were scored similar to the table contained in OECD TG 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- >= 3 - <= 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 8 days
- Irritant / corrosive response data:
- Corrosion was noted 1 and 24 h after application as substantiated by severe reddening, very severe edema, and severe corneal opacity. Severe chemosis was noted after 8 days. Cornea could not be examined due to suppuration.
Any other information on results incl. tables
Findings:
Findings after 1 hour |
Findings after 24 hours |
Findings after 8 days |
|
Test substance: |
Corrosion R+/ED+++/OP++ |
Corrosion R+/ED+++/OP++ |
ED++/severe suppuration; eyeball could not be evaluated |
NaCl: |
Ø |
Ø |
Ø |
R = redness; ED = edema; OP = opacity; Ø = nonirritating; (+) = slight; + = distinct; ++ = severe; +++ = very severe
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
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