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Diss Factsheets
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EC number: 202-268-6 | CAS number: 93-69-6
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Tests on Humans
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Company report outlining positive effects on workers.
Although not a formal clinical study, the information is considered sufficient for classification as Skin Sens 1 - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Human survey done, survey is limited to the effects experienced by those who have been exposed to OTB directly or indirectly at the Consett site of Thomas Swan & Co. Ltd.
- GLP compliance:
- no
- Type of study:
- other: human experience
- Justification for non-LLNA method:
- Human survey done, survey is limited to the effects experienced by those who have been exposed to OTB directly or indirectly at the Consett site of Thomas Swan & Co. Ltd.
- Species:
- other: Human
- Adequacy of induction:
- other: Human observations - workers
- Adequacy of challenge:
- other: Human observations - workers
- No. of animals per dose:
- 19 workers assessed, of whom, several reported adverse effects
- No. with + reactions:
- 11
- Total no. in group:
- 19
- Clinical observations:
- industrial dermatitis
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- industrial dermatitis
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- On balance, the historical evidence suggests that Casamine OTB may be a skin sensitiser rather than simply an irritant.
- Executive summary:
Animal testing cannot be justified on the basis of human data
Reference
In all but one case, dermatitis occured only after a period of time. All of those affected described the problem as beginning in the "sweaty" areas of the skin e.g around the edges of a dust mask or on the wrist underneath a cuff. Symptoms displayed were, itchiness accompanied by tiny blisters underneath the skin surface followed by the formation of keens and skin loss.
The individual operators used the same level of personal protection throughout their stay in this plant - so a change in level of protection does not seem to be a factor in their eventual development of dermatitis. Therefore the skin problems must have occured because either: -
1) the operators became careless regarding their personal protection or
2) sensitisation to the product developed over a period of time.
If 1) then the dermatitis should have cleared up when they resumed their normal level of care. However, in all cases the skin condition persisted until the operators were removed from the plant. This suggests that sensitisation did take place and that a low level of exposure experienced when wearing the protective equipment was now sufficient to cause an allergic reaction, whereas, previously, the same level of exposure had caused no problems.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Conclusions are based on patch-tests performed on workers exposed ot the substance, although it is noted that the results are equivocal and could be irritation. However, using the classification as potential sensitiser, animal testing cannot be justified.
Migrated from Short description of key information:
Positive effects to workers from patch testing gave equivocal results, leading to the conclusion that the substance is probably a potential skin sensitiser. No respiratory effects were reported.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
Positive effects to workers from patch testing gave equivocal results with skin sensitisation, leading to the conclusion that the substance is probably a potential skin sensitiser. No respiratory effects were reported.
Justification for classification or non-classification
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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