Registration Dossier
Registration Dossier
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EC number: 223-498-3 | CAS number: 3926-62-3
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- sodium monochloroacetate
- IUPAC Name:
- sodium monochloroacetate
- Details on test material:
- 96.2 % pure. impurities MCAA 1,45%, sodium carbonate 1,48%, iron 2,7% others each < 1%
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- 3 animals, weight 2.5-2.9 kgs, age 3-5 months
fully climatized room, single cages
temp. 20+-3 degr C
rel. humidity 50+-20
light /dark 12/12
feed Altrom 2123 rabbit feed
water de-ionized chlorinated water ad lib.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- prior to dosing, eyes were examined with fluorescein under UV to exclude existing damage
dosing: 100 mg in left eye; fflushed out after 24 hrs with physiologial saline.
evaluation 1 ,24, 48, 72 hrs and 7 days after dosing
effects on cornea, iris, coniunctivae numerically rated, all other effects recorded in writing
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
Any other information on results incl. tables
| Time post application | 1 hr | 24 hrs | 48 hrs | 72 hrs | 7 days | ||||||||||
| Animal nr | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
| chemosis | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
| Coniunctival erythema | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 2 | 2 | 2 | 2 | 2 | 0 | 0 | 0 |
| Iris | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 |
| Corneal clouding | 0 | 0 | 0 | 2 | 0 | 0 | 2 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 |
| Corneal epithelial defects | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | |||||||
| Clear discharge | x | x | x | ||||||||||||
| White thick discharge | x | x | x | x | |||||||||||
| Corneal bleeding | x | x | x | ||||||||||||
| Red iris | x | x | x | x | x | x | x | x | x | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- moderately irritating, also cat. 2 based on CLP criteria
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