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Diss Factsheets
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EC number: 204-393-1 | CAS number: 120-40-1
- 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:
- March 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: the U.S. Code of Federal Hazardous Substance Act (U. S. Federal Register, 1973, Vol. 38, No. 187, Section 1500:41 and revised annually in the U.S. Code of Federal Regulations, Title 16, Part 1500, Subchapter C-Federal Hazardous Substances Act Regulations)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- EC Number:
- 204-393-1
- EC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Cas Number:
- 120-40-1
- Molecular formula:
- C16H33NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: From recognized breeders whose standards were acceptable to the animal welfare department of toxicology laboratories
- Housing: Grid bottomed metal cages
- Diet (e.g. ad libitum): Antibiotic free pelleted rabbit diet (Product Ref. 680 Dalgety Spillers Limited), ad limitum
- Water (e.g. ad libitum): From holding tanks were available ad limitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 9-18 °C
- Humidity (%): 60-80%
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h day
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL aliquots of the undiluted test substance.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h from dosing.
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm square; the dorsal surfaces of the trunk were clipped free of hair using an Oster Model A2 clipper with Angra blade. Immediately before dosing the left flank of the animals' back was lightly abraded in a criss-cross pattern using the point of a 25 x 0.6mm sterile disposable hypodermic needle. The abrasions were sufficiently deep to damage the stratum corneum but not to penetrate the dermis. The skin of the right flank remained intact.
- Type of wrap if used: Yes, 2.5 cm square surgical lint pads (2.5 cm square) attached to a length of 5 cm wide ‘sleek’ plastic adhesive wrapping was placed on the intact and abraded skin. Then the trunk of the animal was encircled with a length of 'elastoplast' elastic adhesive bandage 7.5 cm wide.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, by gentle wiping with cotton wool soaked in warm water.
- Time after start of exposure: 24 h
SCORING SYSTEM: Erythema, eschar formation and oedema were evaluated numerically as described in the attached background document. The derived primary irritation scores were then evaluated as per the definitions provided in the U.S. Federal hazardous substances act as well as the Draize system of classification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 h and 72 h (abraded + intact)
- Score:
- 2
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks:
- at 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.33
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 1.67 - ca. 1.83
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 1.33 - ca. 1.5
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Well defined erythema of the skin was observed at five abraded sites and four intact skin sites after 24 hour dosing period. The remaining abraded sites and two intact sites exhibited very slight erythema. Slight oedema was also observed at this time at both skin sites in one rabbit and very slight oedema at both skin sites in another rabbit. The severity of this irritant response showed some decline with time (but not reversible within 72 h) and the numerical values given to the irritation observed during the course of the study, when averaged for the group of six rabbits, were 6.3 for erythema and 1.7 for oedema giving a primary irritation score of 2.0 (max. 8). For further details on results, refer to the table under the ' attached backgroud material'.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the study conditions, the test substance was a mild to moderate irritant according to Draize classification system and non irritating according to the U.S. Federal hazardous substances act. It is considered to be Category 2 irritant according to EU CLP classification as the mean average erythema and/or edema score was ≥2.3.
- Executive summary:
A study was conducted to assess the skin irritation potential of the test substance, C12 DEA, in New Zealand White rabbits according to the U.S. Code of Federal Hazardous Substance Act, in compliance with GLP. The substance was applied undiluted to shaved rabbit dorsal abraded and intact skin under an occlusive bandage for 24 h. Well-defined erythema of the skin was observed at five abraded sites and four intact skin sites 24 h after treatment. The remaining abraded site and two intact sites exhibited slight erythema. Slight oedema was also observed at this time at both skin sites in one rabbit and slight oedema at both skin sites in another rabbit. The severity of response declined somewhat over time (but was not reversible within 72 h of treatment). The average numerical scores for the group of six rabbits were 6.3 for erythema and 1.7 for oedema, giving a primary irritation score of 2.0 (max. 8). Under the study conditions, the test substance was irritating to rabbit skin according to the Draize classification system (Nicholson, 1985).
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