Registration Dossier
Registration Dossier
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EC number: 939-488-3 | CAS number: 1471311-93-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: METHOD: FEDERAL REGISTER 38 No.187 § 1500.42 (EYE) PAGE 27019; SEPT. 27, 1973
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate
- EC Number:
- 939-488-3
- Cas Number:
- 1471311-93-9
- Molecular formula:
- C18 H36 N2 O6
- IUPAC Name:
- (2E)-3-({3-carboxy-3-[(2-ethylhexyl)amino]propanoyl}(2-ethylhexyl)carbamoyl)prop-2-enoic acid; (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoic acid; (2E)-4-{2-[bis(2-hydroxyethyl)amino]ethoxy}-4-oxobut-2-enoic acid; 2-[(2-hydroxyethyl)amino]ethyl (2E)-3-[(2-ethylhexyl)carbamoyl]prop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Korantin SC 9437 (now: Korantin MAT)
- Physical state: liquid
- Analytical purity: ca. 100 % (UVCB)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 3 to 4 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: more than 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 2 °C
- Humidity (%): 55 +- 10
- Air changes (per hr): completely air-conditioned, 100 % of fresh air, filtered through Class C fine filter
- 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(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single application, not washed out
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
not washed out
SCORING SYSTEM: as described in OECD 405 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.17
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: mean scores: 0.33 in 2/6 animals, 1 in 2/6 animals, 1.67 in 1/6 animals, 2.67 in 1/6 animals
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.83
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: mean scores: 0 in 1/6 animals, 1 in 5/6 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.73
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean scores: 0.67 in 1/6 animals, 1.67 in 1/6 animals, 2 in 4/6 animals
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 2.67
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean scores: 0.67 in 1/6 animals, 1 in 1/6 animals, 2.33 in 2/6 animals, 3 in 1/6 animals, 3.67 in 1/6 animals
Any other information on results incl. tables
1 h after application: slight reddening rabbits, severe or very severe swelling with vesication and severe or very severe discharge from
the conjunctivae. In addition, slight opacity of the cornea in all rabbits and congestion of the iris in 2 rabbits.
2 to 3 d after application: purulent discharge in 5 rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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