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EC number: 235-921-9 | CAS number: 13048-33-4
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
- EC Number:
- 256-032-2
- EC Name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
- Cas Number:
- 42978-66-5
- Molecular formula:
- C15 H24 O6
- IUPAC Name:
- (1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate
- Details on test material:
- - Name of test material (as cited in study report): Tripropylenglykoldiacrylat
- Physical state: liquid
- Analytical purity: >95%
- Lot/batch No.: 030061P040
- Stability under test conditions: The stability under storage conditions over the study perdiod was guaranteed by the sponsor.
- Storage condition of test material: room temperature, exclusion of light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.12 - 3.22 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor acrea: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with 3 to 6 ml of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours after application
SCORING SYSTEM: according to OECD guideline 405
TOOL USED TO ASSESS SCORE: daylight tubes "Lumilux" (L 58/860 Plus Eco 25x1, Osram, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean value 24/48/72 hours
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
Any other information on results incl. tables
Suppuration, contracted pupil, discharge of blood and injected scleral vessels in a circumscribed area or circular were noted during the observation period within the first 72 hours. All findings were fully reversible within 7 days at the latest.
The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.44 for iris, 2.33 for conjunctival redness and 1.67 for chemosis.
EU-classification: The mean scores calculated over all animals tested were below 2 for corneal opacity, below 1 for iris lesions, below 2.5 for redness of the conjunctivae and below 2 for edema formation. There was only one animal with a mean score of 2.67 for redness, the other two animals were at 2 and 2.33. Therefore the substance is considered to be not irritating to the eye of rabbits according to EU-criteria under the conditions of the study. GHS-classification (UN): As the mean score of corneal opacity was 1 in 3/3 animals and the mean score for redness was 2, 2.33 and 2.67 in the animals respectively and all readings were reversed to 0 at the 7 day reading, the substance has to be classified as mildy irritating to eyes (Category 2B) according to GHS-criteria. The substance is classified in Annex I as irritating to eyes, respiratory system and skin.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
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