Registration Dossier
Registration Dossier
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EC number: 204-814-9 | CAS number: 126-96-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08.11.2010-13.12.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: A guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Name of test material (as cited in study report): Sodium diacetate
- Lot/batch No.:1000022891
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Controls:
- other: the non treatyed eye
- Amount / concentration applied:
- 0.1g
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 96h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 21
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: redness remained on day 21 in two anomals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 5-7 days
- Remarks on result:
- other: congestion noted 1 hour after the test item instillation, totally reversible in 5-7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Sodium diacetae is irritating for eyes, causes irreversible effects on the eyes.
- Executive summary:
The results of the study of eye irritation (according to OECD 405 guideline) shows that Sodium diacetae is irritating for eyes, causing irreversible effects on the eyes. The substance is classified as Causing Irreversible Effects for Eyes: Category 1.
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