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EC number: 271-880-3 | CAS number: 68610-90-2
- 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:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Justification for read-across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Didodecyl fumarate
- EC Number:
- 219-280-2
- EC Name:
- Didodecyl fumarate
- Cas Number:
- 2402-58-6
- Molecular formula:
- C28H52O4
- IUPAC Name:
- didodecyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Didodecyl fumarate
- Physical state: solid, melt/white
- Analytical purity: 93.8 area-% (GC-FID)
- Lot/batch No.: 0008043725
- Expiration date of the lot/batch: Dec 2013
- Stability under test conditions: the stability of the test item under storage conditions over the test period was guaranteed by the sponsor.
- Storage condition of test material: RT
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany.
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 12 weeks (nulliparous and non-pregnant).
- Weight at study initiation: 219 - 241 g (males), 198 - 218 g (females).
- Fasting period before study: no.
- Housing: single housing in Makrolon cage, type III.
- Diet: VRF1 (P); SDS Special Diets Services, 67122 Altrip, Germany.
- Water: tap water ad libitum.
- Acclimation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 25 °C.
- Humidity: 30-70 %.
- Air changes: approx. 10 per hr.
- Photoperiod: 12hrs dark / 12hrs light.
IN-LIFE DATES: from 04 to 19 Mar 2013.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 40 cm² clipped skin of the dorsal and dorsolateral parts of the trunk.
- % coverage: at least 10 % of the body surface.
- Type of wrap if used: the test item was covered with an air-permeable dressing (4 layers of absorbent gauze and stretch bandage).
REMOVAL OF TEST SUBSTANCE
- Washing: with warm water.
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied: 12.50 ml/ kg.
- Concentration (if solution): 400 mg/ml.
- Constant volume or concentration used: yes
- For solids, paste formed: yes, solution was prepared and applied lukewarm. - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: individual body weight shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of clinical signs several times on the day of administration, and at least once daily thereafter each workday for the individual animals.
- Necropsy of survivors performed: yes.
- Scoring of skin findings: individual readings 30 - 60 minutes after removal of the semi-occlusive dressing (day 1), several times and on the last day of observation. Scoring was performed according to Draize.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred within the study period.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination within the study period.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined on the last day of observation.
- Other findings:
- Skin effect at the application site comprised very slight erythema (grade 1) in one out of five male animals and in one out of five female animals and was observed on study day 1.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- LD50 (rat, male/female) > 5000 mg/kg bw
- Executive summary:
The acute dermal toxicity of the category substance to Wistar rats was assessed according to the OECD guideline 402. The clipped skin of dorsal and dorsolateral parts of 5 Wistar rats per sex was exposed to the test substance in corn oil at a limit dose of 5000 mg/kg bw for 24 h under semiocclusive conditions. The substance was removed after 24 hours exposure and the skin was washed. The animals were observed for 14 days for mortality and clinical signs. All the animals were also subjected to necropsy at the end of the observation period; no macroscopic pathological findings were noted. Skin effect at the application site comprised very slight erythema (grade 1) in one out of five male animals and in one out of five female animals and was observed on study day 1.
LD50 > 5000 mg/kg bw (male/female rats)
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