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EC number: 271-653-9 | CAS number: 68603-38-3 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid amide diethanol and SDA Reporting Number: 11-024-00.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 9, 1990 to February 14, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD 404 guideline study, but not in compliance with GLP.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 68425-47-8
- Cas Number:
- 68425-47-8
- IUPAC Name:
- 68425-47-8
- Reference substance name:
- Amides, soya, N,N-bis(hydroxyethyl)
- EC Number:
- 270-355-6
- EC Name:
- Amides, soya, N,N-bis(hydroxyethyl)
- IUPAC Name:
- 270-355-6
- Test material form:
- other: Yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): Marlamid DF 1818
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
80% soybean oil diethanolamide, 10% glycerin, 5% diethanolamine salt of the fatty acids, 3% sodium salt of the fatty acids, 2% free diethanolamine
- Lot/batch No.: 13
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: Single animals in steel cages
- Diet (e.g. ad libitum): K4 diet for rabbit, Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): yes
- Acclimation period: 14 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1°C
- Humidity (%): 60 +/- 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11-01-1990 To: 05-02-1990
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm3 of product on a 6 cm2 skin surface
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 h
- Observation period:
- 25 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- % coverage: 100%
- Type of wrap if used: application site covered with gauze. Additional wWrapping with an elastic band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 4 h
SCORING SYSTEM: OECD 404 method
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: Not applicable
- Score:
- 7
- Max. score:
- 8
- Remarks on result:
- other: Highly irritating
- Irritant / corrosive response data:
- No details provided
- Other effects:
- None
Any other information on results incl. tables
Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 days, 2/3 animals had fully recovered. In the third animal, scabs were falling away.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the undiluted test substance was considered to be highly irritating to rabbit skin. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.
- Executive summary:
A study was conducted to assess the irritation potential of amides, C16-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl) to rabbit skin according to OECD Guideline 404. The test substance was applied undiluted to rabbit skin under an occlusive bandage for 4 h, then washed away with warm water. Animals were observed for 25 d.
Strong erythema and strong oedema were observed in all animals. Slow recovery occured, under thick scabs. After 25 d, 2/3 animals had fully recovered. In the third animal, scabs were falling away.
The overall irritation index was 7/8 so that the undiluted test substance can be considered highly irritating to rabbit skin under the conditions of the study. Further, according to CLP, the test substance may be considered to be Category 2 skin irritant.
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