Registration Dossier
Registration Dossier
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EC number: 282-775-7 | CAS number: 84418-63-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions (limited reporting)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited documentation
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- EC Number:
- 282-775-7
- EC Name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- Cas Number:
- 84418-63-3
- Molecular formula:
- substance is UVCB
- IUPAC Name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
- Lot/batch No.: Bx160491
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: commercial breeder (not further specified)
- Age at study initiation: approx. 10 -13 weeks
- Weight at study initiation: 3185 - 3390 g
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 72 h
Reading time points: 2, 24, 48 and 72 h - Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize scoring system, modified form of the system described by Kay and Calandra (1962) was used for interpretation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: revesibility not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animal #2 and 3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritant / corrosive response data:
- No corneal or iritial effects were observed. Conjunctival effects included slight redness and slight to moderate discharge. The effects had completely regressed by Day 3. Dried secretions on the upper and lower eyelids were present 1 day after dosing in 1 animal.
- Other effects:
- No or slight initial pain was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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