Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-529-6 | CAS number: 97281-29-3
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 11, 2010 to May 25, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Covance Research Products, Inc., Denver
Acclimation: 7 days
Body weights: 2.6 - 3.0 kg for males and 2.9 - 3.3 kg for females
Diet: Fresh PMI Rabbit Chow
Water: ad libitum
Light changes: 12h / 12h - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- To obtain a paste
- Details on dermal exposure:
- 10% of the total body surface (clipped free of hair)
Amount: 3.5 mL - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- The test substance was kept in contact with the skin for 24 h. Dermal responses at test sites were recorded at 24 h postdose and on days 7 and 14 using the numerical Draize scoring. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 h after application and once daily for 14 days. All animals were observed twice daily for mortality. Body weight were recorded pretest, weekly and at termination. Finally, rabbits were examined for gross pathology.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the dermal application
- Clinical signs:
- other: Instances of few feces were observed in one animal. There were no other abnormal signs noted during the observation period. Neither erythema nor oedema was detected.
- Gross pathology:
- Necropsy results were normal.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the study conditions, the rabbit dermal LD50 was determined to > 2000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute dermal toxicity of the test substance, 'di-C18-22 AAEMIM-MS' (active: 100%), according to OECD Guideline 402, in compliance with GLP. Five male and five female New Zealand White rabbits were exposed to 2000 mg/kg bw test substance (3.5 mL in water) under a semi-occlusive type of coverage on a clipped skin free of hair. The test substance was kept in contact with the skin for 24 hours. Dermal responses at test sites were recorded at 24 h postdose and on days 7 and 14 using the numerical Draize scoring. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours after application and once daily for 14 days. Mortality was checked twice daily. Body weight was recorded pre-test, weekly and at termination. Finally, rabbits were examined for gross pathology. All animals survived the dermal application. Instances of few faeces were observed in one animal. There were no other abnormal signs noted during the observation period. Neither erythema nor oedema was detected. Body weight changes and gross examination were normal. Under the study conditions, the rabbit dermal LD50 was determined to > 2000 mg/kg bw (MBRL, 2010).
Data source
Materials and methods
Results and discussion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.