Registration Dossier
Registration Dossier
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EC number: 454-190-9 | CAS number: 324763-51-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004/73/EG
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): 3-amino-2,2-dimethylpropionamide
- Physical state: White, coarse crystalline solid
- Analytical purity: 98.4 % (GC)
- Lot/batch No.: CHAD0424.
- Expiration date of the lot/batch: substance is released until April 2005.
- Stability under test conditions: stable
- Storage condition of test material: Dark & Cool (refrigerator)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany.
- Age at study initiation: No data
- Weight at study initiation: 2.0 kg and 2.8 kg
- Housing: individual
- Diet: Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitum.
- Water: Tap water from an automatic watering system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.1 °C (continuous control and recording)
- Humidity (%): Average of 50.3 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light): 12 h/ 12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and served as a negative control
- Amount / concentration applied:
- 46 mg
- Duration of treatment / exposure:
- single treatment, the eye was held closed for about one second to prevent a loss of test substance
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: OECD/Draize Score
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Remarks on result:
- other: After 7 days : Score 3, after 14 days: Score 2, after 21 days: Score 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Remarks on result:
- other: after 21 days: Score 1
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
The untreated eye ("control eye") was normal at each observation time.
Any other information on results incl. tables
Exposition: Single application to the conjunctival sac of the eyelid; the substance is not washed out |
||||||
Animal |
Reading |
Cornea Opacity |
Iris |
Conjunctiva Redness |
Chemosis |
Remarks |
1 |
1 h |
0 |
0 |
3 |
3 |
Discharge with moistening of the lids and considerable area around the eye. |
1 |
24 h |
0 |
0 |
3 |
1 |
1/4 of the cornea affected, examination after instillation of fluorescein. Discharge with moistening of the lids and hairs just adjacent to the lids. |
1 |
48 h |
1 |
0 |
3 |
1 |
Discharge, any amount different from normal. |
1 |
72 h |
1 |
0 |
3 |
1 |
1/4 of the cornea affected. |
|
mean (24 - 72 h) |
0.67 |
0.00 |
3.00 |
1.00 |
|
1 |
7 days |
0 |
0 |
3 |
1 |
- |
1 |
14 days |
0 |
0 |
2 |
1 |
- |
1 |
21 days |
0 |
0 |
1 |
1 |
- |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS EU
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