Registration Dossier
Registration Dossier
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EC number: 255-137-0 | CAS number: 40908-37-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24.06.1996 to 14.10.1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- EC Number:
- 255-137-0
- EC Name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- Cas Number:
- 40908-37-0
- Molecular formula:
- C11H22N2O
- IUPAC Name:
- N-(2,2,6,6-tetramethylpiperidin-4-yl)acetamide
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleine weiße Russen, Mol:Russian / Chbb: HM
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Concentration: 0.1 g
- Duration of treatment / exposure:
- 1 hour(s)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Comment: rinsed after (see exposure time)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- Because of the severe corrosion the animals were sacrificed 2 hours after treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance showed severe signs of eye irritation already one hour after instillation of the test substance in to the eye. For humane reasons, test animals were sacrificed two hours after instillation of the test substance into the eyes. Thus, according to Regulation (EC) 1272/2008 the test substance is classified into Category 1, Irreversible effects on the eye/serious damage to eyes.
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