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EC number: 943-172-0 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 21, 2015 to October 06, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt
- EC Number:
- 943-172-0
- IUPAC Name:
- Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- Paste
- Details on test material:
- - Name of test material (as cited in study report): Vegetable or animal oil, hydrogenated, reaction products with diethanolamine, maleic anhydride and sodium sulphite
- Lot No.: CH 192435/01
- Purity: Not applicable (UVCB)
- Organic Carbon: 30.2%
- Hydrotox No.: 15/5241
- Origin: DACC
- Stability: Stable within the durability and with appropriate storage conditions
- Solubility in water: ~1 g/L
- Appearance: Light beige liquid/paste
- Storage conditions: Ambient temperature, dark, dry
- Expiration date: July 15, 2015
- Safety directions: H315, H319. Use protective clothing: gloves and protection goggles.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Hsd: Sprague Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age at study initiation: 6-8 wk
- Weight at study initiation: 176 – 200 g
- Housing: Clear polysulphone H-Temp solid bottomed cages (Techniplast Gazzada S.a.r.l., Buguggiate, VA, Italy) measuring 59.5_38_20 cm during acclimatization period and 42.5_26.6_18.5 cm during the study with nesting material provided into suitable bedding bags, Up to 5 of one sex during acclimatisation; individually caged during the study
- Diet (e.g. ad libitum): 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Humidity: 55±15%
- Photoperiod: 12 h dark/12 h light
- IN-LIFE DATES: From: September 21, 2015 To: October 06, 2015
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the dorsal surface of the trunk
- % coverage: approximately 10% of body surface
- Type of wrap if used: elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: After exposure, the adhesive bandage and gauze patch were removed. The treatment area was cleaned by gentle swabbing of the skin with cotton wool soaked with lukewarm water.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 2,000 mg/kg - Duration of exposure:
- 24 h
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 05
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: immediately after the dossing, 1, 2 and 4 h after dosing, and daily thereafter.
- Necropsy of survivors performed: yes.
- Clinical signs: immediately after the dossing, 1, 2 and 4 h after dosing, and daily thereafter.
- Body weight: on the day of dosing (Day 1) and on Days 2, 8 and 15.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred throughout the observation period.
- Clinical signs:
- other: No clinical signs were observed in male or female animals during the 14 d post-dose observation period.
- Gross pathology:
- No abnormalities were found in any animal at necropsy examination performed at termination of the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The acute dermal LD50 of the test substance was found to be >2,000 mg/kg in Hsd:Sprague-Dawley CD rats.
- Executive summary:
A study was conducted to assess the acute dermal toxicity of the test substance in Hsd:Sprague-Dawley rats according to OECD Guideline 402, EU Method B.3 and EPA OPPTS 870.1200,in compliance with GLP. A group of 10 rats (five males and five females) received the test substance at a dose level of 2,000 mg/kg bw dermally through semiocclusive exposure for a period of 24 h. Exposed animals were observed for mortality, clinical signs and body weight changes for 14 d and were then killed and subjected to gross pathological examination. No mortality and clinical signs were noted during the observation period. The body weight changes recorded during the study were within the expected range for this species and age. No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. Under the study conditions, the acute dermal LD50 of the test substance was found to be >2,000 mg/kg (Longobardi C, 2015a).
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