Registration Dossier
Registration Dossier
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EC number: 500-111-9 | CAS number: 51728-26-8 1 - 8.5 moles ethoxylated
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2000 - January 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline No. 405 and under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pentaerythritol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-111-9
- EC Name:
- Pentaerythritol, ethoxylated, esters with acrylic acid
- Cas Number:
- 51728-26-8
- Molecular formula:
- (C2 H4 O)n (C2 H4 O)n (C2 H4 O)n (C2 H4 O)n C17 H20 O8
- IUPAC Name:
- Pentaerythritol, ethoxylated, esters with acrylic acid (> 1 < 8.5 mol EO)
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): SA T001136
- Other name Pentaerythritol, ethoxylated, esters with acrylic acid (PHOTOMER 4172 F)
- Substance type: UVCB
- Physical state: clear to pale yellow liquid
- Lot/batch No.: 0017484908
- Expiration date of the lot/batch: February 2001
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Germany GmbH, Kisslegg, Germany
- Age at study initiation:
- Weight at study initiation: 2.5-3.2 kg bw
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: from 19 December 2000 to 24 January 2001
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- The eyes were examined and the grade of ocular reaction was recorded one hour and 24 hours later. After the first 24 hour reading, fluorescein was instilled. After rinsing with 20 ml 0.9 sodium chloride solution the eyes were eaxmined again. The eyes were also examined 48 and 72 hours and 7, 14 and 21 days after the treatment.
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the first 24 hour reading, fluorescein was instilled abd eyes were rinsed with 20 ml 0.9% sodium chloride.
SCORING SYSTEM: according to Guideline
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study, very well-defined signs of irritation were observed on the treated eyes. Therefire, the test substance shall be classified as an eye irritant.
- Executive summary:
The test substance was investigated for its eye irritating properties according to the method recommended in the OECD Guideline No. 405, "Acute Eye Irritation/Corrosion", Feb. 1987, and EEC Guideline B.5 "Acute Toxicity (Eye Irritation)", Jan. 1997. Three female albino rabbits were exposed to 0.1 ml of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours as well as 7, 14 and 21 days after dosing. Very well-defined signs of irritation were observed on the treated eyes. Therefore, the test substance shall be classified as an eye irritant.
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