Registration Dossier
Registration Dossier
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EC number: 606-712-3 | CAS number: 211450-54-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998/06/26- 1998/07/02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
- EC Number:
- 606-155-6
- Cas Number:
- 188831-96-1
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: SAT980403
- Physical state: clear, colourless, viscous liquid
- Analytical purity: 90 %
- Lot/batch No.: 18009
- Expiration date of the lot/batch: January 1999
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: E.A. Prinzhom, Altenbücker Damm 28, 27333 Altenbücken, Germany
- Weight at study initiation: > 2.5 kg
- Housing: The rabbits were kept individually in a battery of cages with a cage size of 50 x 45 x 40 cm (L x B x H), equipped with a paper disposal system.
- Diet: Harlan Teklad TLM Rabbit Maintenance Diet pelleted breeding diet produced by Harlan Teldad, Shaw 's fann, Blackthom Bicester, Oxon, OX6 OTP, England
- Water: community tap water
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 30 - 70 %
- Air changes: 16/ hour
- Photoperiod: Artificiallight was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: undiluted - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Ocular reactions were assessed 1, 24, 48 and 72 h after treatment
- Number of animals or in vitro replicates:
- 1 male
2 females - Details on study design:
- SCORING SYSTEM:
Ocular reactions were assessed 1, 24, 48 and 72 h after treatment according to the grades for ocular lesions as stipulated in the OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Slight to moderate redness and swelling of the conjunctivae associated with slight ocular secretion were observed in all animals 1 h after instillation. Slight redness and swelling were seen in all animals at 24 h post application. Slight redness was apparent in one animal up to 48 h after instillation. In two of three animals vascular injection on the eyeball was observed at 1 h after instillation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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