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Diss Factsheets
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EC number: 700-777-2 | CAS number: -
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Remarks:
- A confirmatory skin sensitisation patch test of a single worker.
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 07 Sept. 2018 to 11 Sep. 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Following a report of symptoms associated with skin sensitisation in one industrial worker (at a plant manufacturing the test material), a confirmatory human patch test was carried out. The test was was carried out for occupational health reasons, it was not carried out for the purposes of the REACH registration, nor to confirm the classification and labelling of the test material.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- case report
- Principles of method if other than guideline:
- It was confirmed that the patch test that was carried out was a standard recognised test. Patch testing was carried out to the Euopean standard battery, a variety of cosmetic allergens and to the test material, S193308.
The test material was applied to the subject in a staged approach. 0.1% of the test material was applied to the subject at 0 hours. These patches were removed after 48 hours and any reactions recorded. As no reactions were observed at 48 hrs to the 0.1% concentration, 0.5% of the test material was applied to the subject. After 96 hours (after the initial application of the 0.1% test material) the patches for the 0.5% test material were removed. Observations were recorded for both the 0.1% and 0.5% test concentrations. - GLP compliance:
- not specified
Test material
- Test material form:
- not specified
Method
- Type of population:
- occupational
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed: 1
- Sex: male
- Age: 18-65
- Industrial worker - Clinical history:
- - History of allergy or casuistics for study subject or populations: no history of allergy in subject
- Symptoms, onset and progress of the disease: Subject reported facial and hand dematitis and dry eyes, getting progressively worse over the course of four shifts.
- Exposure history: Subject has worked with the test substance for a number of years (exact number unspecified).
- Aggravating factors both in home and workplace: not known
- Family history: not known
- Any other allergic or airway disorders: not known
- Smoking history: not known - Controls:
- not known
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: IQ Ultra patch test units by Chemotechnique (supplied by Crawford Healthcare) (approx 1cm square).
- Vehicle / solvent: Petroleum Jelly
- Concentrations: 0.1% test material at 0 Hours. 0.5% test material at 48 hours.
- Volume applied: ~35 mg
- Testing/scoring schedule: Reactions recorded at 48 and 96 hours. macular erythema record as a +/-. Palpable erythema recorded as +. Palpable erythema extending beyond the test site recorded as ++ and bullae/vesiculation recorded as +++.
- Removal of test substance: Any residue present on removal of patch would be wiped away, the area was not washed.
The test material was applied to the subject in a staged approach. 0.1% of the test material was applied to the subject at 0 hours. These patches were removed after 48 hours and any reactions recorded. As no reactions were observed at 48 hrs to the 0.1% concentration, 0.5% of the test material was applied to the subject. After 96 hours (after the initial application of the 0.1% test material) the patches for the 0.5% test material were removed. Observations were recorded for both the 0.1% and 0.5% test concentrations.
EXAMINATIONS
Examinations were carried out at 48 and 96 hours after the initial patches were applied.
Results and discussion
- Results of examinations:
- RESULT OF CASE REPORT:
At 96 hours (96h after application of the 0.1% test material, 48h after application of the 0.5% test material) clear positive reactions were observed for both the 0.1% and 0.5% applications. A back flare in periocular dermatitis was also observed.
At 48 hours (after application of the 0.1% test material) no reactions were observed.
The test subject had a ++ reaction to 0.5% of test material at 96hrs.
A skin survey of industrial workers at the same plant (test material is only handled at one site) has shown no additional cases.
Applicant's summary and conclusion
- Conclusions:
- The subject had a clear positive result to 0.5% of the test material 48 hours after exposure. The test subject also experienced a back flare in periocular dermatitis which confirmed an allergy to the test material.
- Executive summary:
Introduction
A patch test study was undertaken to confirm a single case of allergic contact dermatitis in an industrial worker.
Results and Conclusion
The subject had a clear positive result to 0.5% of the test material 48 hours after exposure.The test subject also experienced a back flare in periocular dermatitis which confirmed an allergy to the test material.
A skin survey of industrial workers at the same plant (test material is only handled at one site) has shown no additional cases of skin sensitisation.
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