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EC number: 270-112-4 | CAS number: 68411-27-8
- 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
The test substance (10 % aqueous suspension as non-irritating concentration) showed no positive reactions after topical challenge and no positive reactions after systemic challenge in the Guinea Pig Sensitisation Test (Buehler). Under the conditions of this test the test substance is not a sensitiser. This is further supported by results from insult patch test in humans, showing no irritation and no sensitizing potential for several batches of the test item
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:
- 16. Feb. 1979 - 27 Apr. 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Historical study available for this endpoint so used on animal welfare grounds to avoid further testing
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Weight at study initiation: 260 -352 g
- hair was removed from back and flanks by close clipping
- Diet: Wayne animal feed, ad libitum
- Water: ad libitum
- Acclimation: animals were conditioned prior to use - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Test material used in 10 % gravimetric aqueous suspension.
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Test material used in 10 % gravimetric aqueous suspension.
- No. of animals per dose:
- 12
- Details on study design:
- RANGE FINDING TESTS: 4 animals for testing the primary irritation threshold using 50%, 25%, 10% and 5% v/v aqueous concentration; result: score 1 after 16h and 40h ; 10 % concentration was chosen as non-irritating for the main study
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 6 hours
- Test group: 12 animals
- Control group: -
- Site: along the dorsal midline of the back, area 3-4 cm2
- Frequency of applications: three times weekly
- Duration: 3 weeks
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (two applications to determine local and systemic effects
- Day(s) of challenge: two weeks after the last induction application
- Exposure period: 6 hours
- Site: along the dorsal midline of the back (for evaluation of topical effects) as well as ventrally (for evaluation of systemic effects)
- Concentrations: 0.5 ml of 10% gravimetric aqueous test material; 3" x 3" gauze pad wetted with test solution
- Evaluation (hr after challenge): 6 h und 24 h - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no topical (Draize scale 0-4) effects: score 0 and no systemic effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Clinical observations:
- no topical (Draize scale 0-4) effects: score 0 and no systemic effects
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 12.0. Clinical observations: no topical (Draize scale 0-4) effects: score 0 and no systemic effects.
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance (10 % aqueous suspension as non-irritating concentration) showed no positive reactions after topical challenge and no positive reactions after systemic challenge in the Guinea Pig Sensitisation Test (Buehler). Under the conditions of this test the test substance is not a sensitiser.
- Executive summary:
The study was performed to assess the skin sensitisation potential of the test material in a Guinea Pig Sensitisation Test using the Buehler method.
Twelve male guinea pigs (260 -352 g) were exposed to 9 topical, occluded applications (6 hours/day, 3 times weekly) over 21 day period and to two challenge applications 14 days later to determine local and systemic effects. A non-irritating concentration (10 % gravimetric aqueous suspension of the test material) was used. There were no positive reactions after topical challenge and no positive reactions after systemic challenge observed. Under the conditions of this test the test substance is not a sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The study was performed to assess the skin sensitisation potential of the test material in a Guinea Pig Sensitisation Test using the Buehler method. Twelve male guinea pigs (260 -352 g) were exposed to 9 topical, occluded applications (6 hours/day, 3 times weekly) over 21 day period and to two challenge applications 14 days later to determine local and systemic effects. A non-irritating concentration (10 % gravimetric aqueous suspension of the test material) was used. There were no positive reactions after topical challenge and no positive reactions after systemic challenge observed. Under the conditions of this test the test substance is not a sensitiser.
The test materials were tested in a Repeated Insult Patch Test on humans. The objective was to determine by epidermal contact the primary or cumulative irritation and/or sensitisation potential of the test materials. 53 participants, ranging in age from 18 to 70 years, both sex, who qualified for this study. 48 subjects completed this evaluation.
Induction: epicutaneous, semiocclusive application of 20% test material (24 h exposure) three times per week for a total of ten applications. Challenge: epicutaneous, semiocclusive application and site evaluation at 24 and 48 hours after application.
Results: Observations of both treated areas remained negative (no visible reactions) througout the test interval at all participants.
Under the conditions of the study, the test materials do not indicate a potential for dermal irritation and/or sensitisation:
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the substance does not require classification for skin sensitisation according to regulation (EC) 1272/2008.
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