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EC number: 451-900-9 | CAS number: 894406-76-9
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation
The key study was carried out according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and FIFRA 40 CFR. The study was conducted to assess the potential of a 50 % active ingredient formulation of the test material to cause irritation after one topical application to the skin of a New Zealand White male rabbit for four hours. The test item was considered to be corrosive in this skin irritation test.
In addition a GLP study was carried out to evaluate the dermal irritation of Didecyldimethylammonium carbonate and to provide results in the same units as those used to report human exposure, i.e. µg test substance per cm2 skin. The low observed adverse effect concentration (LOAEC) in this study was determined to be 10 µg AI/cm2/day.
Eye irritation
According to column 2 of REACH Regulation (EC) No 1907/2006 Annex VII, section 8. testing for eye irritation was waived, as the available information indicates that the criteria are met for classification as corrosive to the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA 40 CFR
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:
- Weight at study initiation:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To: - Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0.5 - 1 hour, 24 hours
- Number of animals:
- 1 animal
- Details on study design:
- TEST SITE
- Area of exposure: 1x1 inch
SCORING SYSTE
- Draize JH, 1959 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 0.5 - 1 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 0.5 - 1 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Severe irritation was observed in the animal 0.5 - 1 and 24 hours following application. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals.
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered corrosive in this skin irritation test.
- Executive summary:
A study was carried out according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and FIFRA 40 CFR. The study was conducted to assess the potential of a 50 % active ingredient formulation of the test material to cause irritation after one topical application to the skin of a New Zealand White male rabbit for four hours. Signs of skin reaction were observed 0.5 - 1 hour and 24 hours post application. Severe irritation was observed. Changes noted in the colouration and/or texture of the skin included dark and light brown, dark red and purple discolouration, blanching, coriaceousness and necrosis. Due to the evidence of corrosion (necrosis) exhibited in this single animal at the 24 hour reading, this study was terminated without testing in additional animals. The test item was considered to be corrosive in this skin irritation test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
GLP study according to international guidelines.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
Based on the information available the substance is classified and labeled as Skin Corr. 1B, H314: Causes severe skin burns and eye damage according to Regulation (EC) No 1272/2008 (CLP) and C, R34: Causes burns according to Directive 67/548/EEC (DSD).
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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