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Diss Factsheets
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EC number: 213-268-0 | CAS number: 933-48-2
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions: No positive control (not required by 1981 version of Test Guideline) was used, but some reaction and inflamation of the skin due to irritation was observed, showing reactivity of the test system.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (1981)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Vehicle:
- corn oil
- Concentration / amount:
- 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
- Vehicle:
- corn oil
- Concentration / amount:
- 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
- No. of animals per dose:
- 20
- Details on study design:
- 1st application: Induction 5 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge 20 % occlusive epicutaneous - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: treated group and control group
- Dose level:
- 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- only irritation
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: other: treated group and control group. Dose level: 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only irritation.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: treated group and control group
- Dose level:
- 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- only irritation
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: treated group and control group. Dose level: 5% intracutaneous induction, 50% epidermal induction and 20% epidermal challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: only irritation.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Following OECD 406 the test substance diluted at 5%, 50% and 20% in corn oil was successively administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing.
- Executive summary:
Following OECD 406 the test substance diluted at 5%, 50% and 20% in corn oil was successively administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. Under the conditions of this study the substance is considered non sensitizing.
Reference
RESULTS OF TEST
- Sensitization reaction:
0/20 animals positive at 24 hours and at 48 hours = no sensitization
no animals positive in control group
- Clinical signs: only irritation
1st induction, FCA application sites: severe erythema, edema, and necroses
1st induction, vehicle + FCA application sites: severe erythema and edema
1st induction, vehicle application sites: slight erythema and edema
1st induction, vehicle + test substance application sites: slight erythema and edema
2nd induction, test group: severe inflammation of all FCA injection sites with discharge of pus; after 1 hour bleeding wounds from scratching; crust formation within 24 hours
2nd induction, control group: no findings reported
- Other: Mean body weight gain 136.3 g in test group, 126.5 g in control group = expected range
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
According to the outcome of the study no sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing based on the results of the study.
Migrated from Short description of key information:
An OECD 406 test was selected as key study. The substance diluted 20% in corn oil was administerd to 20 animals. No sensitizing effects were observed after 24 and 48 hours. The substance is considered non sensitizing.
Justification for classification or non-classification
Based on the outcome of the study no classification is needed regargding to this endpoint.
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.
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