Registration Dossier
Registration Dossier
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EC number: 238-430-8 | CAS number: 14450-05-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 5 - 12 Feb 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no details on analytical purity given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- EC Number:
- 267-022-2
- EC Name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- Cas Number:
- 67762-53-2
- IUPAC Name:
- 67762-53-2
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbits; New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Inc., Hewitt, NJ, USA
- Age at study initiation: at least 8 weeks
- Weight at study initiation: 2.8 – 2.9 kg
- Housing: individually housed in suspended, stainless steel cages with wire mesh bottoms
- Diet: certified Lab Rabbit Diet HF, No. 5325; PMI Feeds, Inc. St. Louis, MO (approximately 125 g/day while on test)
- Water: automatic watering system (municipal water supply), ad libitum
- Acclimation period: 53 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 34 - 54
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 h, single application without washing
- Observation period (in vivo):
- 3 days
reading time points: 24, 48, and 72 h - Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- One animal exhibited moderate conjunctival redness whereas the other 2 animals showed mild conjuctival redness; all three animals exhibited severe discharge. No iridial or corneal changes were evident throughout the study. At 24 h post-treatment, one animal was free of conjuctival redness. All 3 animals were free of ocular irritation within 72 h after treatment.
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
- Conclusions:
- CLP: not classified
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