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Diss Factsheets
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EC number: 440-990-5 | CAS number: 230309-38-3
- 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:
- 2001 - 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24-02-1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
Constituent 1
- Specific details on test material used for the study:
- Identity: ISOPROPYL N-LAUROYLSARCOSINATE
Description: pale yellow liquid
Batch number: 002013
Purity: 92.9 %
Stability of test item: stable under storage conditions
Expiry date: 31-03-2003
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrl:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test system: Rat, HanBrl: Wist (SPF)
Rationale: Recognized by the international guidelines as a recommended test system
Source: RCC Ltd., Füllinsdorf / Switzerland
Number of animals: 5 m / 5 f per group
Age when treated: 9 - 12 weeks
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Husbandry
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for temperature 22 +/- 3°C and for relative humidity between 30-70 %. 12 hours fluorescent light/12 hours dark, music during the light period.
Accommodation: Makrolon type-4 or type-3 cages
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet ad libitum.
Water: Community tap-water, from Itingen ad libitum.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface. Only those animals without injury or irritation on the skin were used in the test.
On test day 1, the test item was applied at a dose of 1840 mg/kg body weight or 2000 mg/kg evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.
Application volume/kg body weight: 2 or 2.2 mL/kg
Twenty-four hours after the application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed. - Duration of exposure:
- 24 h
- Doses:
- 1840 or 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 m / 5 f
- Control animals:
- no
- Details on study design:
- Mortality: Daily during acclimatization and twice daily during days 1-15
Body weight: On test days 1 (pre-administration), 8 and 15
Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15
Necropsy: All animals at the end of the observation period - Statistics:
- No statistical analysis was used
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the study
- Clinical signs:
- other: Slight scales were observed in one female dosed with 1840 mg/kg on test day 8 until test day 12. All other animals were without clinical signs.
- Gross pathology:
- No macroscopic findings were observed at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of the test item was > 2000 mg/kg bw.
- Executive summary:
A group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 1840 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2 mL/kg.
A second group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2.2 mL/kg.
The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study. Slight scales were observed in one female dosed with 1840 mg/kg on test day 8 until test day 12. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.
The median lethal dose of the test item was > 2000 mg/kg bw.
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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