Registration Dossier
Registration Dossier
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EC number: 277-288-1 | CAS number: 73138-39-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 Sep 2004 - 27 Sep 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2002
- Deviations:
- yes
- Remarks:
- lack of details (test substance, animals, housing, methods)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no rationale for in vivo testing, no initial testing with one animal, no topical anesthetics
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- adopted in 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, coco, esters with 1,3-butanediol
- EC Number:
- 277-288-1
- EC Name:
- Fatty acids, coco, esters with 1,3-butanediol
- Cas Number:
- 73138-39-3
- Molecular formula:
- not applicable, the substance is UVCB
- IUPAC Name:
- Fatty acids, coco, esters with 1,3-butanediol, UVCB
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe)
- Age at study initiation: not stated
- Weight at study initiation: 2.23 kg - 2.43 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: not stated
- Water: not stated
- Acclimation period: 6-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 65-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): not stated
IN-LIFE DATES: 06 Sep 2004 - 11 Sep 2004
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: as supplied by sponsor - Duration of treatment / exposure:
- Single instillation into one eye
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Ocular examinations were performed on both eyes 1, 24, 48 and 72 hours after instillation.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not stated
- Time after start of exposure: not stated
SCORING SYSTEM:
Chemosis: 0-4
Conjunctiva Redness: 0-3
Iris: 0-2
Cornea opacity: 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Remarks:
- individual mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean over
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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