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EC number: 299-434-3 | CAS number: 93882-40-7
- 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:
- 23rd February 1981 - 25th May 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 4 animals per group
- GLP compliance:
- not specified
- Remarks:
- Unlikely due to the age of the study
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate
- EC Number:
- 299-434-3
- EC Name:
- 4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate
- Cas Number:
- 93882-40-7
- Molecular formula:
- C48H86O8S
- IUPAC Name:
- 2-octadecenylsuccinic anhydride, thiodiethanol esterification products
- Test material form:
- solid
- Remarks:
- Waxy Solid
1
- Specific details on test material used for the study:
- Description: Off white, very thick liquid
Density: 0.9987 g/ml at 60-65 degree C
Date of Receipt: February 26, 1981
Storage: Room temperature
Preparation of Dosing Material Mixtures: The test material was warmed in a water bath to 60°C to facilate handling. P40 mixture was required
The material was applied directly on to the exposed skin of the anirial, and spread evenly over the entire area.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Preparation of Animals:
On the day before dosing (approximately 20 hours prior to dosing), the hair of each rabbit was closely clipped from the trunk (dorsal and ventral surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 20% of the body surface
area. No abrasions were made, I.e., the skin of all the animals remained intact.
Husbandry:
Housing: Individually housed
Cage: Suspended, stainless steel
Environmental Conditions: Temperature: monitored twice daily
Temperature range during study: 62 to 76F
Humidity: monitored daily
light cycle: 12 hours light, 12 hours dark
Food:Purina Rabbit Chow
Water Automatic watering system, ad libitum, Municipal water supply
Identification: Each animal was identified with a monel ear tag bearing a unique number prior to testing
Selection: Animal considered unsuitable for study because of poor health or outlying body weights were exlcuded for slection. Animal for study were selected from those remaining.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The material was applied directly on to the exposed skin of the anirial, and spread evenly over the entire area. A layer of 8-ply gauze was then wrapped around the animal to cover the application site. The animal was then wrapped in an impervious plastic sleeve,
designed to contain the test material without leakage or undue pressure. The sleeve was secured with masking tape and Elizabethan collars were placed on all animals. - Duration of exposure:
- Following approximately 24 hours of exposure, the wrappings were removed and the amount of residual test material was estimated visually. After 30 minutes, dermal observations were made.
- Doses:
- Doses groups were 50, 200, 794, 3160 mg/kg
- No. of animals per sex per dose:
- 16 animals (2 animals per sex per dose)
- Control animals:
- not required
- Details on study design:
- Preparation of Animals
On the day before dosing (approximately 20 hours prior to dosing), the hair of each rabbit was closely clipped from the trunk (dorsal and ventral surface and sides from scapular to pelvic area) with an electric clipper, so as to expose at least 20% of the body surface
area. No abrasions were made, i.e. the skin of all the animals remined intact.
Administration of Test Material:
The material was applied directly on to the exposed skin of the anirial, and spread evenly over the entire area. A layer of 8-ply gauze was then wrapped around the animal to cover the application site. The animal was then wrapped in an impervious plastic sleeve,
designed to contain the test material without leakage or undue pressure. The sleeve was secured with masking tape and Elizabethan collars were placed on all animals.
Following approximately 24 hours of exposure, the wrappings were removed and the amount of residual test material was estimated visually. After 30 minutes, dermal observations were made.
Experimental Evaluation (In-Life):
Viability Check: Twice Daily
Observations of Pharmacologic and-Toxicologic Signs: Approximately 1, 2, and 4 hours after dosing and daily thereafter for fourteen days.
Body Weights: Pre-cjose, at the time of clipping (weights used for calculation of doses)
Day of Dosing flay 7 and 14
Evaluation of Skin Irritation: Observations or erythema and edema or other evidence of irritation or injury were made approximately 30 minutes after removal of the occlusive wrapping and aqain at Days 3, 7, 10 and 14.
Post Mortem:
All animals surviving at termination of the observation period (Day 14) were killed by an intravenous or intracardiac overdose of sodium pento’arbital and examined grossly. All abnormalities were recorded but no tissues were saved.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 160 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All of the animals survived at all dose levels
- Clinical signs:
- other: Animals at the 50 mg/kg dose level exhibited slight (well-defined) erythema with occasional edema. 3 of the 4 animals were free of signs of dermal irritation by Day 7 and the fourth animal exhibited only barely perceptible erythena on Day 7 and 10. At the
- Gross pathology:
- One animal (no. 7214, female) in the 50 mg/kg group exhibited a numher of abnormalities in the gastrointestinal tract (red gastric serosa, hardening and thickening of the intestine). The presence of these findings in a single animal in the lowest dose group is not considered to represent an effect of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- No mortality was observed in any acute study performed. No systemic toxicity was observed in any study that would be linked to mortality. No systemic toxicity to cause lethality by dermal application is expected for doses up to 5000 mg/kg as evident by the high concentration tested in the acute oral. Therefore no classification is required.
- Conclusions:
- All of the animals survived at all dose levels; therefore the LD50 is greater than 3160 mg/kg.
- Executive summary:
This study was conducted in order to evaluate the acute dermal toxicity of the Substance. On the day before dosing (approximately 20 hours prior to dosing), the hair of each rabbit was closely clipped from the trunk (dorsal and ventral surface and sides from scapular to pelvic area) with an electric clipper. The material was applied directly on to the exposed skin of the anirial, and spread evenly over the entire area. A layer of 8-ply gauze was then wrapped around the animal to cover the application site. Doses of 50, 200, 794 and 3160 mg/kg of body weiqht were administered to sixteen rabbits (two per sex per dose level) for 24 hours. Animals were monitored for observation of pharmacologic and toxicologic signs at approximately 1, 2, and 4 hours after dosing and daily thereafter for fourteen days. No mortality, bodyweight effects, pharmacologic and toxicologic signs and treatment related macrospic effects were noted in any animals. Erythema and/or edema were observed in all animals and incidences of necrosis were observed in animals treated at > or equal to 794 mg/kg.
All of the animals survived at all dose levels; therefore the LD50 is considered to be greater than 3160 mg/kg.
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