Registration Dossier
Registration Dossier
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EC number: 939-488-3 | CAS number: 1471311-93-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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: FEDERAL REGISTER 38 No. 187 § 1500.41 (SKIN) PAGE 2701, SEPT. 27, 1973
- GLP compliance:
- no
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, with out without abrasion
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- % coverage: 2.5 x 2.5 cm2
- Type of wrap if used: occlusive
SCORING SYSTEM: as descibed in OECD 404 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/72 hours
- Score:
- 1.92
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean scores individual animals: 1 in 1/6 animals, 2 in 4/6 animals, 2.5 in 1/6 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/72 hours
- Score:
- 2.59
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: mean scores individual animals: 2 in 4/6 animals, 3.5 in 1/6 animals, 4 in 1/6 animals
Any other information on results incl. tables
24 h after application: erythema and edema in all rabbits extend far beyond the areas of application (about 1/3 of the back).
3 d after application: erythema and edema principally in the areas of application.
Nothing abnormal was detected upon necropsy on the skin.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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