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Registration Dossier
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EC number: 800-838-4 | CAS number: 1384855-91-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 Jan, 1994 to 14 Feb, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-Propenoic acid, reaction products with dipentaerythritol
- EC Number:
- 800-838-4
- Cas Number:
- 1384855-91-7
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, reaction products with dipentaerythritol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SR 399
- Physical state: Viscous liquid
- Analytical purity: Not known to HRC
- Lot/batch No.: HYH1309
- Expiration date of the lot/batch: January 1995
- Stability under test conditions:
- Storage condition of test material: Room temperature in the dark
- Date received: 14 December 1993
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
- Age at study initiation: 12 to 14 weeks
- Weight at study initiation: 2.8 to 3.2 kg
- Housing: Individually in plastic cages with perforated floors in Building R 14 Room 1.
- Diet: SDS Stanrab (P) Rabbit Diet (ad libitum)
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30-70%
- Air changes: 19 air changes/h
- Photoperiod: 12 h of artificial light (0700 - 1900 h) in each 24 h period
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single exposure
- Observation period (in vivo):
- 14 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
TOOL USED TO ASSESS SCORE: Handheld light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- other: No adverse effects were observed.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritant / corrosive response data:
- Corneal opacities developed in all three animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation.
Any other information on results incl. tables
There were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritating to eyes) based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was determined to irritating to the eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of test substance, DPHA to the rabbit according to EU Method B.5 in compliance with GLP. Three rabbits were each administered a single ocular dose of 0. 1 mL of the test substance in one eye, whereas contralateral eye remained untreated and observed for a maximum of 14 d after instillation. All animals were observed daily for signs of ill health and toxicity. Examination of the eye was made after 1 h and 1, 2 and 3 days after instillation (24, 48 and 72 h). Additional observations were made 4, 7 and 14 days after instillation. Observations of the eyes was aided by the use of a handheld light. Ocular irritation was assessed using the numerical grading system. There were no signs of toxicity or ill health in any rabbit during the observation period. Corneal opacities developed in all animals. No iridial inflammation was observed. A diffuse crimson red colouration of the conjunctivae accompanied by swelling with partial eversion of the eyelids or with the eyelids about half closed was seen in all three animals. The eyes were normal 7 or 14 d after instillation. Under the study conditions, the test substance was determined to be irritating to the eye (Parcell, 1994).
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