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Diss Factsheets
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EC number: 944-243-9 | 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- Deficiencies in biochemical and haematological data; Application only twice per week. (Study was conducted before the implementation of OECD 411)
- GLP compliance:
- no
- Remarks:
- GLP not mandatory at that time.
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-15-alkyl esters, sodium salts
- EC Number:
- 272-575-8
- EC Name:
- Sulfuric acid, mono-C12-15-alkyl esters, sodium salts
- Cas Number:
- 68890-70-0
- IUPAC Name:
- 68890-70-0
- Details on test material:
- - Name of test material (as cited in study report): trade name- Physical state: paste - Purity: 30.1%- Lot/batch No.: CP 3515/6B
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Housing: Individual cages on sawdust- Diet: pelleted diet ad libitum- Water: ad libitum
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- 0.2 mL of an aqueous solution were applied twice weekly.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- No data
- Frequency of treatment:
- Twice weekly
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:0, 5, 10, 12.5, 15% a.s.Basis:other: nominal
- Remarks:
- Doses / Concentrations:0, 200, 400, 500 and 600 mg/kg bw/dayBasis:other: Based on an average weight of 20 g/mouse and a 5 days/week treatment.
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- The mice were weighed weekly, and their water intakes determined twice weekly by subtracting the amount left from that given.
- Sacrifice and pathology:
- At necropsy the liver, spleen, kidneys, heart, brain and testes were removed and weighed. Blocks of these and various tissues were reserved for histological examination.
- Other examinations:
- After 13 weeks skin blood samples were taken by cardiac puncture. The blood samples were used for haematological estimations - packed cell volume, haemoglobin level, mean corpuscular haemoglobin concentration and white cell count.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITYOne mouse treated with 12.5% died after 1 week due to dehydration and anorexia. WATER CONSUMPTIONAt 10% and above the water intake was increased.HAEMATOLOGYHaemoglobin levels reduced and wbc counts increased in high dose males.ORGAN WEIGHTSAbsolute and relative heart weights were higher in high dose females. Relative liver weights were increased in both sexes at the 15% and in females at the 12.5% concentration. Increased absolute kidney weights (males) and relative kidney weights (females) were found at the 15% dose level.GROSS PATHOLOGY & HISTOPATHOLOGYExudate adherent to skin (4/20) was observed at the 15% dose level. Loss of hair colour lateral and ventral to application site observed at all treatment levels. Extensive ulceration and necrosis of the epidermis of the decedent at the 12.5% treatment level. Dose-related ulceration of the epidermis (4/20) with inflammatory exudate (11/20) observed at 15% and 12.5% treatment levels. OTHER FINDINGSAt concentrations of 12.5 and 15%, cytotoxic effects were found in the epidermis.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 other: %
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Corresponding to 400 mg/kg bw.
- Dose descriptor:
- LOAEL
- Effect level:
- 12.5 other: %
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: Extensive necrosis and ulceration of the skin, changes in haematology and organ weights.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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